Healthcare Regulatory Associate Attorney JobotHealthcare Regulatory Associate AttorneyBoston, MA$260,000–$360,000 / yearBillable-hour framework: 2,000-hour annual bonus threshold, with market reporting indicating approximately 1,800 client-billable hours and up to 200 qualifying hours for pro bono and other approved activities. Information collected and processed as part of your Jobot candidate profile, and any job applications, resumes, or other information you choose to submit is subject to Jobot's Privacy Policy, as well as the Jobot California Worker Privacy Notice and Jobot Notice Regarding Automated Employment Decision Tools which are available at jobot.com/legal.
Sr. Medical Affairs Specialist AtriumSr. Medical Affairs SpecialistBoston, MA$75–$85 / hourMedical Affairs Specialist will play a key role in interpreting clinical evidence, responding to complex medical inquiries, and supporting evidence generation strategies that inform product development and healthcare decision-making. Medical Affairs Specialist will leverage clinical expertise and scientific knowledge to support medical communications, evidence dissemination, and cross-functional initiatives that communicate the clinical value of innovative medical technologies.
Contracts and Compliance Specialist GCR Professional ServicesContracts and Compliance SpecialistAyer, Massachusetts$98,000–$100,000 / yearThe Contracts & Compliance Specialist will manage the full lifecycle of government and commercial contracts while ensuring compliance with FAR, DFARS, ITAR, and other applicable regulations. This role is critical to minimizing risk, maintaining contractual integrity, and supporting operations within a highly regulated environment.
NewRecovery Specialist - Case Management - 6 TalentBurst, Inc.Recovery Specialist - Case Management - 6Tewksbury, MA$25–$26 / hourBachelors Degree (BA) or equivalent; or Associates degree in Human Services field PREFERRED - but experience without a degree is fine; two to three years related experience and/or training in the area of chemical dependency. This includes assessing service needs; counseling, developing plans for access to services, liaison with client, families, programs, and service providers.
Manager, Regional Regulatory Lead - LCM CSLManager, Regional Regulatory Lead - LCMWaltham, MA$129,000–$153,000Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products. Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
Director, Regulatory Strategy (Pediatrics) - Remote Agios PharmaceuticalsDirector, Regulatory Strategy (Pediatrics) - RemoteBoston, MARemote$183,549–$275,324 / yearThe current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
Equipment Specialist, Senior - Secret DCS CorporationEquipment Specialist, Senior - SecretBedford, MA$90,220–$130,000 / yearSupport configuration control by processing, tracking, and recommending dispositions for change notices, ecps, deviation/waiver requests, service bulletins, deficiency reports, Airworthiness Directive Notes, and qcps. Provide integrated logistics support, including provisioning, source coding, maintenance data collection, configuration management data, QDR analysis, and identifying alternate sources of supply for DMS/MS issues.
DC Maintenance Specialist III O'Reilly Automotive StoresDC Maintenance Specialist IIIDevens, MA$37.25–$41.25Responsible for daily maintenance and repair issues of all facilities and grounds systems, including structural components, electrical work, plumbing, roofing repairs, carpentry, painting, welding, parking lot maintenance, etc. Ensure ongoing preventative maintenance for all systems operational in the DC; including HVAC systems, electrical units, lighting, roofing system, generators, parking lots, fans, restrooms and other plumbing systems, etc.
NewQuality Control Laboratory Specialist (Hematology) American National Red CrossQuality Control Laboratory Specialist (Hematology)Dedham, MAAmeriCorps, the federal agency that brings people together through service, and its partners — the Peace Corps, AmeriCorps Alums, National Peace Corps Association, and the Service Year Alliance — launched Employers of National Service to connect national service alumni with opportunities in the workforce. Perform moderate to high complexity laboratory testing procedures and interpret various testing procedures on donor specimens, and blood products; Identify and quarantine products/samples that don’t meet quality requirements.
Project & Contract Finance Specialist CFSProject & Contract Finance SpecialistBoston, MA$80,000–$100,000 / yearThe Growth: The business is scaling rapidly through acquisitions and organic expansion, creating strong long-term career growth opportunities. The Opportunity: This is a hands-on Project Finance Specialist role focused on supporting the full lifecycle of contract and billing administration.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAAt Boston Scientific, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Regulatory Affairs Specialist II, Expansion WhoopRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
Sr. Specialist, Regulatory Affairs LeMaitreSr. Specialist, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistCambridge, MA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
Regulatory Affairs Specialist Integrated Resources, IncRegulatory Affairs SpecialistMansfield, MassachusettsContractorRegulatory Affairs SpecialistJob title: Regulatory Affairs SpecialistLocation: Mansfield, MA Duration: 5+ months (possibility of extension)Roles and Responsibilities:· The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files necessary for outside U.S. notification and registration of medical devices, pre-clinical and/or clinical research, familiarity with ISO 14971, U.S. regulation 21 CFR 820, EC Directives 93/42/EEC as amended by Directive 2007/47/EC, EN ISO 13485, an understanding of basic safety requirements for medical devices, knowledge of current trends within U.S. and European medical device regulations, and intimate knowledge of regulations regarding reprocessing of medical devices in the U.S.· Provide regulatory assessments of manufacturing, design, material, and labeling changes.· The major deliverables are generally regulatory assessments, US letter to file (RAD), global regulatory strategy plans (GRSP), collaboration with RA International team to determine impact, and collaboration with the project team to review DHF documentation including but not limited to test protocols and reports.·
Usability And Regulatory Affairs Specialist SentecUsability And Regulatory Affairs SpecialistLincoln, RI$90,000–$110,000 / yearDevelop and maintain usability engineering documentation, including use specifications, task analyses, use-related risk analyses, and the usability engineering file, in accordance with IEC 62366 and FDA guidance. You will work closely with engineering, clinical, and quality teams to identify and mitigate use-related risks—ultimately helping bring high-impact medical technologies to market.
Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning IncContract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876)Tewksbury, MA$71,252–$97,972 / yearOur health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets.
Sr. Specialist, Regulatory Affairs LeMaitre Vascular IncSr. Specialist, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirements-such as EU MDR 2017/745-into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBoston, MAIn addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies.
Senior Regulatory Affairs Specialist Siemens HealthineersSenior Regulatory Affairs SpecialistWalpole, MARemoteFull timeIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Regulatory Specialist for Center for Anesthesia Research Excellence Lahey Hospital and Medical CenterRegulatory Specialist for Center for Anesthesia Research ExcellenceBoston, MA$60,008–$88,005 / yearJob Description: Essential Responsibilities: Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients. Customer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving.
Regulatory Affairs Specialist II, Expansion Whoop IncRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
NewSr. Regulatory Affairs Specialist Glaukos CorpSr. Regulatory Affairs SpecialistBurlington, MAOur constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Regulatory Specialist for Center for Anesthesia Research Excellence Beth Israel Lahey HealthRegulatory Specialist for Center for Anesthesia Research ExcellenceBoston, MassachusettsCustomer Service: Ability to provide a high level of customer service to patients, visitors, staff and external customers in a professional, service-oriented, respectful manner using skills in active listening and problem solving. Prepare and submit applications (industry, cooperative groups and PI initiated studies), respond to IRB comments on applications submitted and work with study team in getting studies activated for enrollment of patients.
Senior Regulatory Affairs Specialist Advanced Regenerative Manufacturing Institute IncSenior Regulatory Affairs SpecialistManchester, NHFull timeD. is preferredMinimum of 8 years of direct work experience in human medical product regulatory affairs; experience with clinical trials of drugs or biologics is preferredThorough knowledge of U.S. FDA medical product regulations, current industry practices, and experience with interpretation and application of said regulations and practicesAbility to influence colleagues, clients, and Institute members at all levels in the organizationExceptional written and verbal communication skillsProficient with Microsoft software productsAbility to multi-task, meet deadlines, and set prioritiesAbility to work independently and thrive in a fast-paced, rapidly changing environmentCollaborative attitude, sense of curiosity, and eagerness to impact positive changeCommitment to quality, scientific integrity, and company missionStrong analytical and proactive problem-solving skills with a strong attention to detailAbility to work independently and manage competing prioritiesBy applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws. Overview The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a Member-based non-profit, member-driven, public-private partnership with a mission to advance the bioeconomy and transform the future of human health.
Regulatory Affairs Specialist, EHS, North America Henry Schein IncRegulatory Affairs Specialist, EHS, North AmericaMA$56,604–$88,443 / yearDevelop and deliver employee environmental, health, and safety (EHS) awareness and training programs to ensure compliance with applicable federal, state, and international regulations, including OSHA, OSHA State Plans (e.g., Cal/OSHA), DOT, IATA, IMO, and EPA requirements. Proficient in Microsoft Office applications, including PowerPoint, and experienced with project management methodologies and tools commonly used in the medical device or pharmaceutical industries.
Regulatory & Clinical Specialist LivaNova PlcRegulatory & Clinical SpecialistBoston, MARemote$85,000–$95,000 / yearManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers , and check that all recruitment emails come from an @livanova.com email address.
NewFederal Regulatory Specialist Transdev North America IncFederal Regulatory SpecialistBoston, MAIf required, Transdev will appoint a highly experienced Federal Regulatory Specialist to support the General Manager and executive leadership team in ensuring compliance with Federal Railroad Administration (FRA) requirements, federal transit regulations, and public funding obligations during service commencement and transition operations. This senior advisory role provides regulatory, operational, and financial compliance support, helping ensure the commuter rail system operates in accordance with federal requirements, funding conditions, and industry best practices.
Regulatory & Clinical Specialist LivaNovaRegulatory & Clinical SpecialistBoston, MARemote$85,000–$95,000 / yearManage the overall development and approval process for assigned documents (CEP, CER, etc.) within timelines, including documentation generation, initiation of the review process, discussions on proposed revisions, and document completion in collaboration with other team members. If you are concerned that an offer of employment might be a scam or that the recruiter is not legitimate, please verify by searching for "See Open Jobs" on https://www.livanova.com/en-us/careers , and check that all recruitment emails come from an @livanova.com email address.
Specialist Regulatory Compliance Environmental American Tower CorpSpecialist Regulatory Compliance EnvironmentalWoburn, MAThis team ensures the appropriate level of environmental review is completed to address the FCC's National Environmental Policy Act's ("NEPA") compliance requirements and the Comprehensive Environmental Response Compensation and Liability Act's ("CERCLA") due diligence considerations for wireless facility development and redevelopment. Contribute to monthly team meetings focused on project review trends, environmental services trends, cross-functional training needs, and customer service best practices.
Principal Specialist - Regulatory Affairs & Compliance Gorton'sPrincipal Specialist - Regulatory Affairs & ComplianceGloucester, MassachusettsMonitor and evaluate emerging regulatory trends, enforcement actions, recalls, and global food safety risks to proactively manage regulatory risks and ensure company strategies remain aligned with current and future compliance requirements. - Provide technical expertise to support Gorton’s businesses in all areas related to ingredients, labeling and claims, legal, governmental and regulatory issues, including FDA registration requirements.
Regulatory Reporting & Compliance Specialist American Family Insurance GroupRegulatory Reporting & Compliance SpecialistBoston, MA$62,000–$103,000 / yearAdditional Preferred Qualifications: Ability to translate reporting requirements into controlled, repeatable workflows using SQL/BigQuery, Excel, and work-tracking tools (e.g., Jira), with strong documentation to enhance operational efficiency and transparency. Work closely with regulators, states, boards, bureaus, vendors and stat agents related to new and existing regulations, new product, state development, legacy retirements, new data source development.
Regulatory Reporting & Compliance Specialist (Hybrid) American Family Insurance GroupRegulatory Reporting & Compliance Specialist (Hybrid)Boston, MA$62,000–$103,000 / yearAdditional Preferred Qualifications: Ability to translate reporting requirements into controlled, repeatable workflows using SQL/BigQuery, Excel, and work-tracking tools (e.g., Jira), with strong documentation to enhance operational efficiency and transparency. Work closely with regulators, states, boards, bureaus, vendors and stat agents related to new and existing regulations, new product, state development, legacy retirements, new data source development.
Regulatory Affairs Specialist Medtronic PlcRegulatory Affairs SpecialistBoston, MAThe following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program). If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Associate Regulatory Affairs Director AstraZeneca PlcAssociate Regulatory Affairs DirectorCambridge, MA$135,624.80–$203,437.20 / yearAs a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.
Regulatory Affairs Manager AstraZeneca PlcRegulatory Affairs ManagerCambridge, MA$109,244.80–$163,867.20 / yearSupport operational and compliance activities for assigned deliverables, including generating work requests and submission content plans, submission tracking, TMF, and document management utilizing the support and input of GRO, MCs, CROs and/or alliance partners where relevant. The RAM provides regulatory expertise and guidance on procedural and documentation requirements to GRET, GRST and cross-functional teams working flexibly within and across regions to ensure the delivery of business objectives.
Sr. Regulatory Affairs Spclst RadNet IncSr. Regulatory Affairs SpclstSomerville, MAQualifications include: • Bachelor's degree in relevant field (or equivalent experience) • 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Regulatory Affairs Specialist, this position will: • Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Director, Regulatory Affairs – Global Regulatory Strategy Monte Rosa Therapeutics, IncDirector, Regulatory Affairs – Global Regulatory StrategyBoston, MassachusettsFull timeOverview: Monte Rosa Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs, with a focus on immunology. Lead the preparation, submission, and maintenance of regulatory applications, including INDs, CTAs, marketing applications, Annual Reports, Orphan Drug Designation, Requests for Fast Track, and other regulatory documents.
Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co IncSenior Director Regulatory Affairs Liaison- General MedicineBoston, MA$190,800–$300,300 / yearRequired Skills: Corporate Commercial, Cross-Cultural Awareness, Drug Development, Exercises Judgment, Global Health, Global Market, Healthcare Innovation, Interpersonal Relationships, In Vitro Diagnostics (IVD), Multiple Therapeutic Areas, Oral Communications, Orphan Drugs, Pharmaceutical Regulatory Affairs, Process Improvements, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Issues, Regulatory Management, Regulatory Strategy Development, Written Communication. As the Global Regulatory Lead (GRL), the Senior Principal Scientist functions as the regulatory single, accountable, global point of contact on the project team and interacts with the global regulatory agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more company investigational and marketed drugs/biologics in early- and/or late-stage development.
Sr. Regulatory Affairs Spclst DeephealthSr. Regulatory Affairs SpclstSomerville, Massachusetts$120,000–$165,000 / yearFull timeRegulatory Affairs Specialist, this position will: · Represent Regulatory Affairs on cross functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices. · Create and ensure maintenance of technical documentation (such as clinical evaluation reports, risk management reports, 510(k) notification) as required for obtaining and/or maintaining regulatory approval/clearance for DeepHealth products.
Prin Regulatory Affairs Spec - Core Surgical innovations Medtronic PlcPrin Regulatory Affairs Spec - Core Surgical innovationsBoston, MAResponsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
NewRegulatory Affairs Expert - Remote YO AI LabsRegulatory Affairs Expert - RemoteBoston, MassachusettsRemoteThe role involves assessing clinical documents, ensuring compliance with regulatory guidelines, identifying inconsistencies, and providing clear, evidence-based feedback to improve AI-generated regulatory content. We are seeking an experienced Regulatory Affairs Specialist to support AI-driven healthcare projects by reviewing and evaluating regulatory documentation.
Regulatory Compliance Specialist Telus CorpRegulatory Compliance SpecialistBoston, MA$110,000–$145,000 / yearExcellent written and verbal communication skills, with the ability to explain complex regulatory concepts clearly to diverse audiences-from plan sponsors and senior leadership to Operations colleagues with varying levels of regulatory familiarity. Partner with plan sponsors as their trusted regulatory advisor, providing timely guidance on legislative changes affecting their employees and retirees; working alongside their legal counsel and internal teams.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Prin Regulatory Affairs Spec Medtronic PlcPrin Regulatory Affairs SpecBoston, MAIf you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
Regulatory Affairs Professional Siemens HealthineersRegulatory Affairs ProfessionalWalpole, MAFull timeAs a Regulatory Affairs Professional, you will be responsible for : Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA PMA Annual Reports, PMA 30-day notices and supplements, 510(k) submissions and notes to file, IVDR Class D recertifications, significant change notifications, and other regulatory applications as required. "It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.".
Director, Regulatory Affairs Liaison, Vaccines & Infectious Diseases Merck & Co IncDirector, Regulatory Affairs Liaison, Vaccines & Infectious DiseasesBoston, MA$210,400–$331,100 / yearRequired Skills: Biological Sciences, Biostatistics, Clinical Judgment, Clinical Trial Planning, Clinical Trials, Communication, Cross-Functional Collaboration, Detail-Oriented, Infectious Disease, Leadership, Medical Writing, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Intelligence, Regulatory Issues, Regulatory Strategy Development, Regulatory Writing. Primary activities include, but are not limited to: Functions with a high degree of independence and provides regulatory oversight for assigned products, functioning as the single, accountable, global regulatory point of contact on those projects within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.
Senior Professional Regulatory Affairs - Ad and Promo Dechra Pharmaceuticals LtdSenior Professional Regulatory Affairs - Ad and PromoBoston, MAEnsure Dechra meets the applicable regulations and accepted practices established by Local, Regional, and Federal Competent Authorities as they pertain to product / project assignments by providing awareness, assessment, and appropriate documentation as required for promotional review. This role has a broad and varied scope and the successful candidate will have responsibility for duties including: Review and approval of Advertising and Promotional Materials.