Documentation Control Specialist EDA StaffingDocumentation Control SpecialistBeverly, MA$55,000–$65,000 / yearFull timeThis position works closely with Engineering, Manufacturing, Operations, and Quality teams to ensure documentation, training records, regulatory requirements, and quality processes remain accurate, compliant, and audit-ready. We are seeking a Document Control & Regulatory Compliance Specialist to play a key role in maintaining and improving our Quality Management System (QMS).
NewAccounts Payable Specialist Vaco LLCAccounts Payable SpecialistAndover, MA$60,000–$65,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewPayroll Specialist Vaco LLCPayroll SpecialistBoston, MA$35–$40Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewDirector/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, Regulatory Agios PharmaceuticalsDirector/Senior Director, Regulatory Labeling Strategy, Advertising, and Promotion, RegulatoryCambridge, MA$229,562–$344,342 / yearThe current base salary range for this position at the Director level is expected to be between $183,549 and $275,324 annualized and the current base salary range for this position at the Senior Director level is expected to be between $229,562 and $344,342 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 partner cross-functionally with Legal, Commercial, Corporate Communications, and Medical, as well as other cross-functional stakeholders within the Research and Development organization, to enable compliant, effective messaging, development of labeling, and promotional and non-promotional materials to supports business objectives while protecting the company’s integrity and reputation.
NewContracts 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.
NewSenior Payroll Specialist Vaco LLCSenior Payroll SpecialistFramingham, MA$80,000–$90,000Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewCollections Specialist Vaco LLCCollections SpecialistNorth Andover, MA$47,840–$49,920Determining compensation for this role (and others) at Vaco by Highspring depends upon a wide array of factors including but not limited to: the individual’s skill sets, experience and training; licensure and certification requirements; office location and other geographic considerations; other business and organizational needs. Determining compensation for this role (and others) at Vaco/Highspring depends upon a wide array of factors including but not limited to the individual’s skill sets, experience and training, licensure and certifications, office location and other geographic considerations, as well as other business and organizational needs.
NewDirector, 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.
Recovery Specialist - Case Management - 6 TalentBurst, Inc.Recovery Specialist - Case Management - 6Danvers, MA$25–$26 / hourEssential Functions/Key Responsibilities: Responsible for maintaining individual case load, which involves conducting individual intake evaluations, treatment and aftercare planning, medication management support, and safety planning as needed. This includes assessing service needs; counseling, developing plans for access to services, liaison with client, families, programs, and service providers.
NewEquipment 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.
TECH SVCS - IT Lab Computing Support Specialist ECLAROTECH SVCS - IT Lab Computing Support SpecialistDevens, MA$43.27–$45.90 / hourMinimum of 2+ years of experience working in regulated industries such as Biotech, Pharmaceutical, and Medical Devices familiarity supporting benchtop instruments and applications within a GxP compliant manufacturing or laboratory setting. Review and approve validation lifecycle documents as part of CSV activities, supporting the risk assessments, specifications, pre- and post-approval of qualification testing.
Customer Support Specialist Wakefield Thermal Solutions, Inc.Customer Support SpecialistNashua, NHAdminister and manage key business processes for assigned customer accounts, including quotations, sample and prototype coordination, pre-production, production, order management, quality support, and ongoing customer service. Building on over four decades of leadership and experience, Wakefield Thermal designs, manufactures, and sells thermal management products that remove excess heat generated by electronic components.
NewSr. Desktop Support Specialist Bluestone BankSr. Desktop Support SpecialistRaynham, MA$29–$32 / hourProvides advanced assistance and support to users for routine and complex telephone equipment issues, printer and copy machine support, bank email system(s) support, general file access administration, and workstation software/hardware support, including repair, moves, installations, deployments, and upgrades. Completes the IT daily checklist in the absence of the Senior Systems Administrator, including validation of nightly server backups, antivirus updates, Windows and non-Windows updates, server capacity status, secure email, and other operating system updates.
NewClinical Practice Specialist Dana-Farber Cancer InstituteClinical Practice SpecialistCambridge, MA$129,800–$148,400 / yearWe strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications.
NewProfessional Development Specialist-2 Dana-Farber Cancer InstituteProfessional Development Specialist-2BOSTON, MA$113,200–$133,800 / yearSupports nurses in the management of symptom distress related to cancer and/or its treatment based on advanced knowledge of the etiology of cancer, the rationale for treatment, patient and family responses and needs, and associated nursing interventions. Demonstrates expertise in areas of oncology clinical practice, by participating in patient care to identify opportunities for improvement, assess staff performance, and facilitate implementation of new practices.
NewProfessional Development Specialist-1 Dana-Farber Cancer InstituteProfessional Development Specialist-1BOSTON, MA$113,200–$133,800 / yearSupports nurses in the management of symptom distress related to cancer and/or its treatment based on advanced knowledge of the etiology of cancer, the rationale for treatment, patient and family responses and needs, and associated nursing interventions. Demonstrates expertise in areas of oncology clinical practice, by participating in patient care to identify opportunities for improvement, assess staff performance, and facilitate implementation of new practices.
NewMedical Director, Sickle Cell Disease, Clinical Development Agios PharmaceuticalsMedical Director, Sickle Cell Disease, Clinical DevelopmentBoston, MA$221,600–$369,333 / yearThe current base salary range for this position is expected to be between $221,600 and $369,333 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. Follow important developments and relevant trends in scientific literature and develop/maintain contracts with external experts to support understanding of the candidate drug effects and to gain strategic insights to the further development and placement of study and overall program.
NewSenior Director, Program Leader, Corporate Strategy Agios PharmaceuticalsSenior Director, Program Leader, Corporate StrategyCambridge, MA$229,562–$344,345 / yearDemonstrated ability to drive successful product launch and commercialization of innovative, first-in-class therapies, including lifecycle management (LCM) planning and execution; experience leading programs from late-stage development through commercial readiness and post-launch LCM strategies strongly desired. Define and continuously evolve the Target Product Profile, Clinical Development Plan, regulatory pathway, market access strategy, and commercial positioning in close partnership with cross-functional leaders and aligned with patient needs.
Associate Director, State Government Affairs - Remote Agios PharmaceuticalsAssociate Director, State Government Affairs - RemoteBoston, MARemote$153,541–$230,312 / yearThe current base salary range for this position is expected to be between $153,541 and $230,312 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. Our team’s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities.
NewSenior Manager, Medical Affairs Operations - Remote Agios PharmaceuticalsSenior Manager, Medical Affairs Operations - RemoteBoston, MARemote$131,035–$196,553 / yearManage the execution of Agios’ patient advocacy conference plans for PK deficiency, thalassemia, and sickle cell disease; participate in cross-functional planning meetings; obtain compliance approval for related materials; and attend virtual and in-person conferences, when needed. Provide operational and project management support to the US patient advocacy team, ensuring smooth day-to-day coordination across priorities, stakeholders, and deliverables, and flex to support various other functions within Medical Affairs as needs arise.
Risk Management and Policy Specialist EclaroRisk Management and Policy SpecialistCanton, MAFull timeUpgrade current WISP to latest version of NIST800-53v5:Continue evaluation comparison of current WISP which is at NIST800-53v4 to newer NIST800-53v5. ECLARO's client is a market-leading insurance company, providing property, casualty, and specialty insurance services within the United States.
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.
NewSenior Regulatory Affairs Specialist Dentsply SironaSenior Regulatory Affairs SpecialistWatertown, MAWe may collect the following categories of personal information in connection with the submission of your resume or application materials to us for employment, and if hired, your employment with us: identifiers (e.g., name, address, email address, birthdate); personal records (e.g., telephone number, signature, education information, criminal background information, passport number and visa information); consumer characteristics (e.g., sex, marital status, veteran status, race, disability, sexual orientation); professional or employment information (e.g., resume, cover letter, employment history, background check forms, references, certifications, transcripts and languages spoken); and inferences from personal information collected (e.g., a profile reflecting abilities and aptitudes). The above categories of personal information are collected for the following business purposes: performing recruitment and hiring services; processing interactions and transactions (e.g., to comply with federal and state laws requiring us to maintain certain records, managing the workforce); and security (e.g., detecting security incidents, protecting against fraudulent or illegal activity).
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAThe anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) - see www.bscbenefitsconnect.com-will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Your responsibilities will include: Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed.
Principal Regulatory Affairs Specialist Medtronic PlcPrincipal Regulatory Affairs SpecialistBoston, MAThis role is responsible for shaping and executing global regulatory strategies, with a strong focus on pre-market submissions and early engagement with the global regulatory partners and/or regulatory authorities, as appropriate, across the United States, European Union, China, Japan, and Australia. Strategic direction is expected to support a number of regulatory applications which may include, FDA Pre-submissions, PMDA consultations, original IDEs and PMAs, IDE and PMA Supplements/Reports, Shonin applications, China PTR submissions, and EU MDR Technical Documentation.
Regulatory Affairs Specialist Dentsply Sirona IncRegulatory Affairs SpecialistMADentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Key Responsibilities: Prepares and submits international regulatory submissions to obtain and maintain regulatory approvals for medical devices, including 510(k) submissions and technical files for CE Marking.
Usability and Regulatory Affairs Specialist SentecUsability and Regulatory Affairs SpecialistLincoln, RI$80,000–$100,000Develop 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.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistMA$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.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBoston, 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 Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirementssuch as EU MDR 2017/745into 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 Companys 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.
Regulatory Affairs Specialist HP Hood LLCRegulatory Affairs SpecialistWilmington, MADocument maintenance & communication for support of claims, product and packaging regulatory compliance, customer requests utilizing Hood systems, posting and monitoring portal content, and providing support to operations and food safety & quality for document requests during third party and customer audits. Education and Experience: A BA/BS degree in biology, chemistry, food science, food regulatory affairs, nutrition, packaging science, or related scientific field, 2-5 years of professional experience, preferably in regulatory in the food industry.
Senior Regulatory Affairs Specialist Wolters Kluwer N.V.Senior Regulatory Affairs SpecialistWaltham, MAAbout the Role: As the Senior Regulatory Affairs Specialist, you will serve as a regulatory lead expert supporting the expansion of our Software as a Medical Device (SaMD) portfolio across global markets. Serve as primary author and owner of major submissions, including 510(k), De Novo requests, CE Technical Documentation, UKCA dossiers, and global regulatory filings.
Regulatory Affairs Specialist Hologic IncRegulatory Affairs SpecialistMarlborough, MAOur Regulatory Affairs team plays a vital role in bringing innovative compliant and safe medical technologies to market helping advance early detection diagnosis and treatment solutions that improve the lives of women around the world. Hologic is seeking aRegulatory Affairs Specialistresponsiblefor assisting in the management of all regulatory activities within the defined countrygeographical areas by performing the following under supervision of RA management or more senior RA personnel.
NewSenior Regulatory Affairs Program Specialist Zoll MedicalSenior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Regulatory Affairs Specialist LGC LtdRegulatory Affairs SpecialistMilford, MAOur integrated portfolio of products, services and expertise supports our purpose of Science for a Safer World and we have embodied our mission by working with customers to enable research into life-altering treatment for disease and illness worldwide. LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, parental responsibilities, religion, or belief.
Regulatory Specialist Canadian Nuclear Laboratories LtdRegulatory SpecialistBurlington, MARemoteFrom building the next generation of clean nuclear and hydrogen energy technologies, to developing targeted cancer treatments, to continuing our global leadership in environmental remediation-we are driven by impact, innovation, and purpose. Bachelor''s (Honours) or Master''s or PHD in Engineering or Science from a university of recognized standing; OR membership in an engineering or scientific professional organization authorized by statute to establish qualification for membership in that organization.
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. The Regulatory and Clinical Specialist is a liaison with the organization working with various groups to effectively communicate and collaborate on the deliverables and meet the project deadlines in line with the regulatory requirements.
GSS Principal Regulatory Affairs Specialist, Intelligence & Strategy Hologic IncGSS Principal Regulatory Affairs Specialist, Intelligence & StrategyMarlborough, MAWhy join Hologic: You will have the opportunity to get in on the ground floor at a high growth world class manufacturing facility working on life-saving medical devices with potential for future growth. At Hologic, we are seeking a Quality Assurance Engineer - Product Quality to play a critical role in managing product holds .
Senior Regulatory Affairs Program Specialist Zoll Data Systems, Inc.Senior Regulatory Affairs Program SpecialistChelmsford, MARemoteThe Acute Care Technology division of ZOLL Medical Corporation develops and delivers innovative lifesaving products and software solutions to EMS, hospital, public safety, and military customers globally. Evaluate and resolve regulatory and technical issues due to extensive knowledge of medical device manufacturing and related regulatory requirements in this product sector through a clear understanding of the product development lifecycle.
Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director PricewaterhouseCoopers LLPAsset and Wealth Management External Audit - Regulatory Reporting Specialist - DirectorMA$134,000–$348,500 / yearAs an Asset and Wealth Management External Audit - Regulatory Reporting Specialist - Director, you will play a pivotal role in guiding clients through complex regulatory landscapes, enhancing their internal controls, and mitigating risks effectively. PwC does not intend to hire experienced or entry level job seekers who will need, now or in the future, PwC sponsorship through the H-1B lottery, except as set forth within the following policy: https://pwc.to/H-1B-Lottery-Policy.
Regulatory Compliance Specialist II Expert In Recruitment SolutionsRegulatory Compliance Specialist IICambridge, MAThe RSO Specialist, manages authoring of CMC regulatory documents (modules 1.2, 2.3 and 3) to support Marketing Authorizations and other documentation that support site registrations, specific country documentation, and Annual reports. The RSO Specialist may represent RSO on M&S and MSAT project teams when product or valence-related regulatory site expertise is required and serve as the Regulatory interface between M&S, MSAT and GRA.
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.
Financial Crime Risk Specialist - Regulatory Response & Audit Oversight The Toronto-Dominion BankFinancial Crime Risk Specialist - Regulatory Response & Audit OversightBoston, MA$91,000–$145,600 / yearTotal Rewards at TD includes base salary and variable compensation/incentive awards (e.g., eligibility for cash and/or equity incentive awards, generally through participation in an incentive plan) and several other key plans such as health and well-being benefits, savings and retirement programs, paid time off (including Vacation PTO, Flex PTO, and Holiday PTO), banking benefits and discounts, career development, and reward and recognition. Employee/Team Accountabilities: Participates fully as a member of the team, supports a positive work environment that promotes service to the business, quality, innovation and teamwork and ensure timely communication of issues / points of interest.
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.
NewPermitting & Regulatory Compliance Specialist II Core States GroupPermitting & Regulatory Compliance Specialist IIBurlington, MARemoteHEALTHCARE - Competitive health benefits including HSA with employer contribution, life insurance options, and supplemental coverage options, giving you the flexibility to select the coverage that best fits your needs and lifestyle. Core States Group designs, builds, and manages programs and projects across North America and has been recognized on top lists throughout the architecture, engineering, and construction (A/E/C) industry.
Regulatory Compliance Specialist Brigham and Women's HospitalRegulatory Compliance SpecialistCharlestown, MA$63,252.80–$102,596 / yearResponsible for supporting the implementation and maintenance of the compliance program, including conducting audits, providing training, monitoring compliance activities, investigating and reporting animal compliance concerns and assisting with investigations to promote a culture of ethical conduct and mitigate compliance risks within the organization. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success.
Regulatory Affairs Talent Pool (US & Canada) Parexel International CorpRegulatory Affairs Talent Pool (US & Canada)MARegulatory Affairs is a diverse and dynamic field, offering pathways for specialists across multiple disciplines: • Labeling Operations - ensuring accuracy and compliance in product information. Our Regulatory Affairs opportunities offer the ability to work remotely from home, empowering you to contribute globally while maintaining balance in your personal and professional life.
Manager, Regulatory Affairs LeMaitreManager, 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.