Quality Manager JobotQuality ManagerGardner, MA$75,000–$90,000 / yearThe Quality Manager will be responsible for implementing and maintaining our Quality Management Systems, ensuring compliance with ISO 9001, and driving improvements using Six Sigma, Lean Manufacturing, and other quality tools. 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.
Program Manager, Senior - Secret DCS CorporationProgram Manager, Senior - SecretBedford, MA$90,220–$120,000 / yearThe Air Force Program Execution Office for PEO Digital (AFPEO/HB) has the collective Air Force Materiel Command (AFMC) mission responsibility to manage and execute the modernization, development, testing, production, fielding, and sustainment of the PEO Electronic Systems portfolio, which includes over 130 programs for the United States Air Force (USAF) and foreign allies. Bachelor’s degree in a professional engineering discipline from an ABET-accredited program, and minimum of 12 years of experience in the respective technical/professional discipline, including at least 5 years supporting DoD programs.
Construction Project Manager cumberlandfarmsincConstruction Project ManagerWESTBOROUGH, MA$111,840–$139,800You can find us operating under the following store banners: Certified Oil, Cumberland Farms, Fastrac, Kwik Shop, Loaf N Jug, Minit Mart, Sprint Food Stores, Tom Thumb, Turkey Hill, and Quik Stop. Expedite Permits: The CFI-PM must research and investigate current requirements to secure all necessary building, trade, and construction permits for each project assigned, coordinate or initiate the application process for these permits, and track the release of all permits until all are received.
Operations Manager - OEM Manufacturing - Worcester, MA Michael Page USAOperations Manager - OEM Manufacturing - Worcester, MAWorcester, MA$100,000–$135,000 / yearFull timeThe Operations Manager is responsible for overseeing procurement, production, logistics, and safety in a project‑driven manufacturing. supporting pharmaceutical and biotechnology customers with high‑quality, critical process systems used in regulated environments.
Safety Manager - Electrical Construction - $135k Michael Page USASafety Manager - Electrical Construction - $135kWorcester, MA$100,000–$135,000 / yearFull timeWith a strong reputation for quality, collaboration, and innovation, they deliver projects spanning ground-up builds, tenant fit-outs, solar installations, and energy-efficient systems. Our client is a full-service electrical construction firm serving commercial, industrial, and renewable energy markets across New England and New York.
Safety Manager - Electrical Construction - Worcester, MA Michael Page USASafety Manager - Electrical Construction - Worcester, MAWorcester, MA$100,000–$135,000 / yearFull timeWith a strong reputation for quality, collaboration, and innovation, they deliver projects spanning ground-up builds, tenant fit-outs, solar installations, and energy-efficient systems. Our client is a full-service electrical construction firm serving commercial, industrial, and renewable energy markets across New England and New York.
Sr. Project Manager - Water and Wastewater Construction Michael Page USASr. Project Manager - Water and Wastewater ConstructionWaltham, MA$150,000–$175,000 / yearFull timeProject Manager - water and wastewater construction will: Oversee and manage water and wastewater construction projects from initiation to completion. Project Manager - Water and Wastewater Construction will receive: Competitive salary ranging from $150,000 to $175,000 USD annually.
Operations Manager - Equipment Manufacturing - Hudson, MA Michael Page USAOperations Manager - Equipment Manufacturing - Hudson, MAHudson, MA$100,000–$130,000 / yearFull timeThis Operations Manager leads daily operations across production, procurement, and logistics within a fabrication and equipment manufacturing environment. With consistent double-digit growth, it has built a strong reputation for delivering engineered solutions to leading global clients.
NewProgram Manager, Senior - TS DCS CorporationProgram Manager, Senior - TSBedford, MA$90,220–$180,000 / yearEPASS support is required to execute the major GNS programs in support of the C2ISR Division, to include AF DCGS Network Infrastructure Transformation (NIT), Extended Tether Program (ETP), and Global Command and Control System – Air Force Infrastructure (GCCS-AF (I)). The C2ISR Division provides worldwide life cycle support across the spectrum of the C2ISR capabilities-based enterprise; including supply, distribution, materiel management, acquisition, system engineering and maintenance, financial planning and budgeting, security, flight test, and contracting functions.
NewProgram Manager, Senior DCS CorporationProgram Manager, SeniorBedford, MA$90,220–$180,000 / yearEPASS support is required to execute the major GNS programs in support of the C2ISR Division, to include AF DCGS Network Infrastructure Transformation (NIT), Extended Tether Program (ETP), and Global Command and Control System – Air Force Infrastructure (GCCS-AF (I)). The C2ISR Division provides worldwide life cycle support across the spectrum of the C2ISR capabilities-based enterprise; including supply, distribution, materiel management, acquisition, system engineering and maintenance, financial planning and budgeting, security, flight test, and contracting functions.
Manager, Regulatory Affairs Deciphera Pharmaceuticals IncManager, Regulatory AffairsWaltham, MA$116,000–$160,000 / yearThe Manager, Regulatory Affairs will partner cross-functionally to support high-quality regulatory submissions and help drive successful interactions with global health authorities. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable).
Senior Manager, Business Process Office, Global Regulatory Affairs (GRA) TakedaSenior Manager, Business Process Office, Global Regulatory Affairs (GRA)MassachusettsRemotediv>By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.
Regulatory Affairs Manager Dentsply Sirona IncRegulatory Affairs ManagerWaltham, MADentsply 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. This role works closely with business partners for registrations in their respective countries to ensure compliance globally and acts as an internal champion for initiatives aimed at improving business systems and compliance.
Regulatory Affairs Manager II Post Market WerfenRegulatory Affairs Manager II Post MarketBedford, Massachusettsli>Lead field corrections and removal for on-market products, determining classification and regulatory agency reportability based on assessed risk, preparing comprehensive regulatory strategy, authoring field communication, leading cross-functional team to ensure timely customer notification, reporting and interfacing with regulatory agencies (as required), and supervising the regulatory team that assembles and maintains the necessary support records. This leadership role owns all elements related to post-market regulatory compliance to meet worldwide regulatory requirements, including vigilance reporting, recall (product correction and removal) management, on-market product change assessment, and the post-market surveillance (PMS) program.
Regulatory Affairs Project Manager - Vascular (on-site) Abbott LaboratoriesRegulatory Affairs Project Manager - Vascular (on-site)Westford, MA$99,300–$198,700 / yearCertification is a plus (such as RAC from the Regulatory Affairs Professionals Society).Previous experience with 510k / PMA submissions Experience working with hardware/ software devicesFamiliarity with Predetermined Change Control Plans (PCCPs)Experience with Medical DevicesMust be able to juggle multiple and competing prioritiesExercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutionsHas a sound knowledge of a variety of alternatives and their impact on the businessApply NowLearn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.comFollow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. WHAT YOU'LL DO Provide regulatory input to product lifecycle planningMonitor regulatory outcomes of initial product concepts and provide input to senior regulatory managementAssist in the development of multi-country regulatory strategy and update strategy based upon regulatory changesAssist in regulatory due diligence for potential and new acquisitionsUtilize technical regulatory skills to propose strategies on complex issuesMonitor trade association positions for impact on company productsAnticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams.
Senior Manager, Regulatory Affairs, Operations Xenon PharmaceuticalsSenior Manager, Regulatory Affairs, OperationsNeedham, MassachusettsPharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. style="min-height:1.5em">Bachelor’s degree in a scientific discipline with 8+ years of regulatory documentation and operations experience in a pharmaceutical, biotechnology or contract research organization (CRO), including experience in project coordination and document management systems and processes.
Regulatory Affairs Manager PGI FoodsRegulatory Affairs ManagerLowell, Massachusetts$105,000–$125,000 / yearp style="margin:0px">The Regulatory Affairs Manager serves as the company's regulatory expert and trusted business partner, ensuring that products, ingredients, packaging, and labeling comply with all applicable regulatory requirements while supporting the successful launch of new products. Position Overview: .
Manager Regulatory Affairs-Chemistry Manufacturing & Controls CMC AbbVie IncManager Regulatory Affairs-Chemistry Manufacturing & Controls CMCWaltham, MAli>Represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations Product Teams, for assigned projects; negotiates with and influences team members with support of management to maximize chances for first pass approval of regulatory submissions and stays abreast of regulatory procedures and changes in the external regulatory environment. US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html.
Senior Manager, Regional Regulatory Lead - North America, Seqirus Vaccines CSL Behring LLCSenior Manager, Regional Regulatory Lead - North America, Seqirus VaccinesWaltham, MA$154,000–$182,000 / yearp>The Senior Manager, Regional Regulatory Lead (RRL), North America Seqirus Vaccines in the Global Regulatory Strategy (GRS) team is a member of the GRA GRS Vaccines Therapeutic Area (TA) and contributes to the vision and goals of CSL as: Regulatory leader who leverages North America regulatory experience / expertise 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. To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Sr. Manager/Associate Director, Regulatory Affairs Oruka TherapeuticsSr. Manager/Associate Director, Regulatory AffairsWaltham, CaliforniaOruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Sr. Manager/Associate Director, Regulatory Affairs Oruka Therapeutics IncSr. Manager/Associate Director, Regulatory AffairsWaltham, MA$161,000–$187,000 / yearOruka's mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. This individual will work closely with cross-functional teams to provide regulatory guidance throughout product development, support health authority interactions, and help ensure the timely preparation and submission of high-quality regulatory applications.
Senior CMC Regulatory Strategy Manager GSK plcSenior CMC Regulatory Strategy ManagerWaltham, MA$144,375–$240,625 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Directs and communicates complex regulatory issues independently across the company and with external agencies and third parties as necessary, to influence project and policy issues that are aligned with business needs ensuring optimum position for the company.
Manager, Regulatory Policy and Stakeholder Engagement Eversource EnergyManager, Regulatory Policy and Stakeholder EngagementWestwood, MassachusettsRole and Scope of Position: Responsible for implementing strategic regulatory initiatives and developing and building key regulatory relationships that will enable the development of strong regulatory policy and drive regulatory successes. Current guidelines require employees to work at least three days in the office, including Tuesdays and Wednesdays, with the third day set by the employee and supervisor based on department needs.
Contractor, Sr. Manager/AD, Regulatory Affairs StratAcuity Staffing Partners IncContractor, Sr. Manager/AD, Regulatory AffairsWaltham, MA$100–$126 / hourIn terms of professional development, Everforth Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Everforth Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts.
NewSr Manager, Regulatory Compliance Staples IncSr Manager, Regulatory ComplianceFramingham, MAThe specific base pay may be influenced by a variety of factors to include the candidate''s experience, skill set, education, geography, business considerations, and internal equity. Our merchandising team aims to deliver the best value and selection to our customers through products, services and solutions all centered around our customers' needs.
Senior Vice President, Regulatory Administration/Filings Manager The Bank of New York Mellon CorpSenior Vice President, Regulatory Administration/Filings ManagerWestborough, MA$102,000–$220,000 / yearp>In this role, youll make an impact in the following ways: Lead multiple teams of Regulatory Administration and Filings staff providing clients with legal guidance on SEC filings such as prospectuses, proxy statements, and board minutes. BNY Mellon can act as a single point of contact for clients looking to create, trade, hold, manage, service, distribute or restructure investments & safeguards nearly one-fifth of the world''s financial assets.
NewSystem Quality & Regulatory Programs Manager UMass Memorial HealthSystem Quality & Regulatory Programs ManagerWorcester, Massachusettsdiv>Are you an internal caregiver, student, or contingent worker/agency worker at UMass Memorial Health? Reporting directly to the SVP, Chief Quality Officer / Chief Clinical Informatics Officer, the System Quality & Regulatory Programs Manager provides enterprise‑level leadership and strategic oversight for quality, safety, and health equity regulatory programs across the UMMH system.
System Quality /Regulatory Program/ Process Manager UMass Memorial Health Care IncSystem Quality /Regulatory Program/ Process ManagerWorcester, MA$111,384–$200,491.20 / yearp>Reporting directly to the SVP, Chief Quality Officer / Chief Clinical Informatics Officer, the System Quality & Regulatory Programs Director provides enterprise‑level leadership and strategic oversight for quality, safety, and health equity regulatory programs across the UMMH system. This role builds and sustains strong collaborative relationships across all levels of the organization, working closely with clinical and administrative leadership, as well as quality managers and analysts at both the entity and system levels.
Regulatory Affairs Associate Ajinomoto Cambrooke, Inc.Regulatory Affairs AssociateAyer, MassachusettsThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.
Regulatory Affairs Associate Ajinomoto Health & Nutrition North America, Inc.Regulatory Affairs AssociateAyer, MassachusettsThe employee will on occasion be required to enter the warehouse, lab, and/or production environment requiring the use of personal protective equipment such as safety shoes, safety glasses, ear plugs, hair and/or beard nets and meet other GMP policies and guidelines. Joining ACI means becoming part of a diverse team of talented people who want to build their careers while contributing back to society in a positive way.
NewRegulatory Affairs Associate:$71,449+ YR Ajinomoto Cambrooke, Inc.Regulatory Affairs Associate:$71,449+ YRAyer, MAAbility to sit for extended periods, perform visual inspections of labels/documents, occasional lifting up to 25 lbs., standing/walking/bending as needed. Perform regulatory research, document reviews, label proofreading, version control, and cross-functional coordination to enable compliant product release.
Associate Director Regulatory Affairs Viridian Therapeutics IncAssociate Director Regulatory AffairsWaltham, MAp>Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to-day regulatory activities for product development and approval in alignment with the corporate strategy for Viridian's Thyroid Eye Disease (TED) and TSHR portfolio. Communicate with internal and external stakeholders, including members of the leadership teams, to ensure cross-functional alignment, work with Regulatory CMC and Regulatory Operations teams to establish and meet timelines for regulatory submissions.
Director, Global Labeling - Regulatory Affairs SpringWorks Therapeutics IncDirector, Global Labeling - Regulatory AffairsBillerica, MA$182,100–$273,100 / yearYour Role: The Director of Global Labeling (Director of GL) provides strategic regulatory labeling expertise and operational leadership to cross functional teams, ensuring the successful development of company core data sheets (CCDS), regional labeling (US Prescribing Information [USPI] and EU Summary of Product Characteristics [SmPC]) and target product labels, in line with target product profiles and overall program goals. About SpringWorks Therapeutics: SpringWorks Therapeutics, a healthcare company of Merck KGaA, Darmstadt, Germany, is a commercial-stage biopharmaceutical company dedicated to improving the lives of patients with rare tumors.
NewHead of Regulatory Affairs Pulpdent CorpHead of Regulatory AffairsMAPulpdent is third-generation family-owned business that is widely respected for its innovative products and authentic company culture, which promotes work-life balance, employee retention, and product excellence. The Head of Regulatory Affairs will lead and evolve Pulpdent's global regulatory strategy across the full product lifecycle-from R&D and commercialization to quality assurance and post-market surveillance.
Director of Quality Assurance and Regulatory Affairs Biomedical SearchDirector of Quality Assurance and Regulatory AffairsLittleton, MAThe Director will oversee Quality and Regulatory functions across multiple sites, ensuring compliance with FDA, ISO 13485, and other applicable regulations while partnering closely with Operations, Engineering, and Executive Leadership. This individual will play a key role in shaping quality strategy, strengthening the Quality Management System (QMS), leading audits and CAPA activities, and developing a high-performing QA/RA team.
Associate Director, CMC Regulatory Affairs (Hematology/Oncology) Regeneron PharmaceuticalsAssociate Director, CMC Regulatory Affairs (Hematology/Oncology)Warren, MassachusettsRemotePerform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents; • Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks. • Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Vice President, Regulatory Affairs *PC 884 Miltenyi BiotecVice President, Regulatory Affairs *PC 884Waltham, Massachusettsp>Your Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.â¯The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance’s. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.â¯Manage and develop staff, if required, including staff professional development and project oversight accountability.⯠.
Executive Director, Regulatory Affairs Dyne Therapeutics IncExecutive Director, Regulatory AffairsWaltham, MA$250,000–$310,000 / yearp>Role Summary: The Executive Director, Regulatory Affairs serves as a visionary leader who shapes long-term program regulatory strategy, collaborates on regulatory functional strategy, and drives organizational impact across Dyne''s regulatory operations. This position requires a leader who contributes to department-wide strategy, develops corporate policies and processes that influence the organization''s direction, and ensures alignment with the mission of delivering meaningful outcomes for patients.
Director, Regulatory Affairs Nova BiomedicalDirector, Regulatory AffairsWaltham, MA$210,000–$270,000 / yearul>Oversees and leads the Regulatory Affairs function to ensure global regulatory requirements are met for Nova products including but not limited to: U.S. FDA 21 CFR Part 820 (Quality Management System Regulation (QMSR), ISO 13485:2016,; EU Regulation (EU) 2017/746 (IVDR); UK Medical Devices Regulations 2002 (UK MDR 2002); Australian Therapeutic Goods (Medical Devices) Regulations 2002 (incl. Reggiannini%40aicompanies.com%7Cf6fba6f305dd4f5db48208dd4cfb41b1%7Cef83c7bf14e34752af743ef60a50e893%7C0%7C0%7C638751364205790035%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=EsnZO9uH6fllGdFfgcxIXEsPp3qEXFI%2FT5rnvjqL6MU%3D&reserved=0" rel="nofollow noopener noreferrer" target="_blank">https://advancedinstruments.showpad.com/share/DmsEd5QTLlqemTYABlvDW.
Director, Regulatory Affairs Strategy - Oncology Regeneron PharmaceuticalsDirector, Regulatory Affairs Strategy - OncologyWarren, MassachusettsFor additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. Critical thinking, leadership skills, assertiveness, excellent negotiation and project management skills as evidenced by past performance on drug development project teams.
Vice President, Regulatory Affairs *PC 884 Miltenyi Biotec GmbHVice President, Regulatory Affairs *PC 884Waltham, MA$295,600–$347,764 / yearp>Your Role: The role will be responsible to lead the regulatory strategy for US Biomedicine efforts in alignment with global efforts.?The role will oversee industry-specific practices, ensure all government and company regulations are being met, assessing regulatory risks and interfacing with regulatory authorities to ensure the company meets all set requirements and guidance's. Lead team members that provide regulatory affairs content and requirements for regulatory submissions and review this content for conformance with established requirement.?Manage and develop staff, if required, including staff professional development and project oversight accountability.?.
Associate Director Regulatory Affairs – Vascular (on-site) AbbottAssociate Director Regulatory Affairs – Vascular (on-site)Westford, Massachusettsli>Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.
Director, Regulatory Affairs CMC Madrigal PharmaceuticalsDirector, Regulatory Affairs CMCWaltham, Massachusettsp/>This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Strategy Lead, CMC Mature, Regulatory Affairs GSK plcStrategy Lead, CMC Mature, Regulatory AffairsWaltham, MA$113,850–$189,750 / yearGSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients' needs and have the highest probability of success. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
Director, Regulatory & Clinical Affairs Nova Biomedical CorpDirector, Regulatory & Clinical AffairsWaltham, MA$210,000–$270,000 / yearp>The Director of Regulatory & Clinical Affairs will oversee and lead the Regulatory Affairs Department to ensure global regulatory requirements are met for Nova products, including compliance with US FDA CFR Title 21 Part 820 (Quality System Regulation), ISO 13485:2016, Australian Therapeutic Goods (Medical Devices) Regulations (TG(MD)R Sch. This role serves as Deputy Person Responsible for Regulatory Compliance (PRRC) and is responsible for the leadership, development, and management of an effective and compliant Regulatory Affairs team, working closely with cross-functional partners to ensure processes meet regulatory expectations and support operational excellence.
Director, Regulatory Affairs CMC Madrigal Pharmaceuticals IncDirector, Regulatory Affairs CMCWaltham, MA$207,000–$253,000 / yearp>This role provides strategic, tactical and operational regulatory CMC leadership to support clinical trial applications, market registrations and post-approval submissions, along with managing the day-to-day regulatory CMC activities of assigned projects for development and/or commercial products. Please know that Madrigal does not conduct interviews via text or in chat rooms; conduct interviews via Skype, RingCentral or solely via telephone; charge candidates an advance fee of any kind (e.g., fees for purchasing equipment); nor does it offer positions of employment without undergoing a thorough recruiting process.
Director, Regulatory Affairs, Commercial (Advertising & Promotion) Xenon PharmaceuticalsDirector, Regulatory Affairs, Commercial (Advertising & Promotion)Needham, MassachusettsPharmaceuticals (NASDAQ:XENE) is a neuroscience-focused biopharmaceutical company dedicated to drug discovery, clinical development, and commercialization of life-changing therapeutics for patients in need. Total Rewards program includes base salary, target bonus, and stock options, as well as a full range of benefits including medical, dental, vision, short-& long-term disability, accidental death & dismemberment, and life insurance programs, Employee Assistance Program, travel insurance, and retirement savings programs with company matching contributions.
Director, Regulatory Operations Keros Therapeutics IncDirector, Regulatory OperationsLexington, MA$206,000–$227,000 / yearWith a focus on developing differentiated product candidates that are designed to alter TGF- signaling, we aim to target the pathways critical for the growth, repair and maintenance of blood cells and a number of tissues, including bone, skeletal muscle, adipose and heart tissue. Primary Responsibilities: Oversee all Regulatory Operations deliverables, including management of Health Authority correspondence/submission archives, business administration of the Veeva Vault Regulatory Information Management system, submission management, and training of associated business processes.
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.