Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

Senior Regulatory Affairs Lead - Medical Devices

Cure Talent

Cure Talent is partnering with a global medical device company to hire a Regulatory Affairs Lead in the United Kingdom. The role is hands‑on and senior IC within a three‑person team, covering EU MDR, US FDA submissions, and global registrations. You will review Technical Documentation, guide classification, and support audits and inspections, mentoring peers and shaping regulatory strategy across Class II/III devices. #J-18808-Ljbffr Cure Talent

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead - Medical Devices in Boston, MA vacancy
  • A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization of its digital products and AI technologies. The role involves providing regulatory input on product development, maintaining compliance... 
    Senior
    Medical device
    Remote job

    Hmixray

    Somerville, MA
    4 days ago
  • $124k - $152k

    Caris Life Sciences is seeking a Manager - Regulatory Affairs in Boston, MA. The role involves leading regulatory strategies for in vitro diagnostic projects...  ...6 years of regulatory submission experience in medical devices or IVDs. The position involves collaboration with... 
    Senior
    Medical device

    Caris Life Sciences

    Boston, MA
    3 days ago
  • $120k - $150k

    A medical device company in Massachusetts seeks a Regulatory Affairs lead dedicated to clinical and medical device products. This role involves overseeing FDA submissions and managing clinical studies. Candidates should have 7-10 years of experience in Clinical Affairs... 
    Senior
    Medical device
    Remote job

    Evident Microscopy

    Needham Heights, MA
    1 day ago
  • $212k - $333.19k

     ...therapies to patients worldwide. About the role As Senior Director and Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations Human Factors, you...  ...with global health authorities Reviews and approves medical device development design control documentation,... 
    Senior
    Medical device
    Full time
    Temporary work
    Local area
    Worldwide
    Night shift

    JobRx, Inc.

    Boston, MA
    17 hours ago
  • The Mullings Group in Boston is seeking a Senior NPD Sourcing Leader to enhance front-end sourcing for new product development. This...  ...bring 7-10 years of sourcing experience, particularly in the medical device sector, and must possess strong analytical and negotiation skills... 
    Senior
    Medical device

    The Mullings Group

    Boston, MA
    3 days ago
  • Biogen is seeking a Senior Device Quality Engineering Lead in Cambridge, MA to ensure quality oversight of design...  ...control and risk management for medical devices. This hybrid role involves...  ...quality processes, and compliance with regulatory standards. A BS in Biomedical/... 
    Senior
    Medical device

    Biogen

    Cambridge, MA
    3 days ago
  •  ...and extensive knowledge in clinical data management for medical devices. This role focuses on leading data collection systems and ensuring data integrity...  ...project management skills. This is a contract position with a mid-senior level designation. #J-18808-Ljbffr Katalyst CRO
    Senior
    Medical device
    Contract work

    Katalyst CRO

    Boston, MA
    3 days ago
  •  ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class II medical devices. Responsibilities include managing FDA submissions, ensuring regulatory compliance throughout product development, and collaborating... 
    Senior
    Medical device

    Medella Life

    Cambridge, MA
    4 days ago
  •  ...Biomedical, located in Norwood, MA, seeks a Senior Quality Engineer responsible for...  ...transfer and production. This role requires leading quality initiatives, supporting equipment...  ...'s degree in Engineering, 7+ years in a medical device environment, and strong knowledge of... 
    Senior
    Medical device

    Nova Biomedical

    Norwood, MA
    3 days ago
  • Sanofi in Morristown, NJ is looking for a GRA Device Associate - Medical Devices and Combination Products (Senior Manager) to drive regulatory strategies for innovative medical devices. You will partner with various teams, ensure compliance, and navigate complex regulatory... 
    Senior
    Medical device

    Sanofi

    Cambridge, MA
    3 days ago
  • RadNet is seeking a Sr. Regulatory Affairs Principal in Somerville, Massachusetts...  ...compliance for high risk medical products, including AI...  ...cross-functional teams and lead regulatory submissions, ensuring...  ...framework for innovative medical devices, requiring both strategic... 
    Medical device

    RadNet

    Somerville, MA
    3 days ago
  • A leading pharmaceutical company is seeking a Regulatory Affairs Manager in Boston, MA. This role will involve overseeing regulatory...  ..., developing strategies for medical devices, and managing submissions with...  ...offers a contract with a mid-senior level designation. #J-18808-... 
    Medical device
    Contract work

    Katalyst CRO

    Boston, MA
    3 days ago
  • $170k - $220k

    WHOOP is seeking a Staff Regulatory Affairs Associate to develop regulatory strategies for Software as a Medical Device (SaMD) and other digital health solutions. This role requires 8+ years of experience in Regulatory Affairs, particularly in the medical device industry... 
    Medical device

    WHOOP

    Boston, MA
    4 days ago
  • £50k - £60k per year

     ...000 to £60,000 Discipline: Regulatory Job ref: CT3002 Post Date:...  ...is partnering with a global medical device company recognized for its life...  ...for a Regulatory Affairs Lead to join their team in a hands...  ...Lead, you will operate as a senior individual contributor within... 
    Medical device
    Permanent employment

    Cure Talent

    Boston, MA
    1 day ago
  • $170k - $220k

    WHOOP is looking for a Staff Regulatory Affairs Associate to shape the regulatory strategy for digital health and AI-enabled technologies...  ...involves developing regulatory approaches for Software as a Medical Device (SaMD) and serving as a primary advisor to cross-functional... 
    Medical device

    jobr.pro

    Boston, MA
    4 days ago
  • Axoft is seeking a Senior Manufacturing Quality Engineer in Cambridge, Massachusetts. This role focuses on supporting the scale-up...  ...degree in Engineering and 5-7 years of relevant experience in the medical device industry are required. The position offers opportunities for... 
    Senior
    Medical device

    Axoft

    Cambridge, MA
    3 days ago
  •  ..., Massachusetts, is seeking a Senior Product Safety & Compliance Engineer to manage regulatory compliance and product certification...  ...product lines, including medical devices. You will be responsible for...  ...preparing regulatory filings, leading project reviews, and ensuring... 
    Senior
    Medical device

    SharkNinja

    Needham Heights, MA
    3 days ago
  • Vertex Pharmaceuticals in Boston is seeking an Operational Area Quality Senior Manager to lead quality oversight for assembly manufacturing of medical devices and combination products. You will review MBRs/EBRs/DHRs, investigate deviations, CAPAs, and drive continuous... 
    Senior
    Medical device

    Vertex Pharmaceuticals

    Boston, MA
    4 days ago
  •  ...Pharmaceuticals seeks an Operational Area Quality Senior Manager to provide quality leadership for assembly manufacturing of medical devices and combination products. You will oversee...  ..., with a focus on continuous improvement and regulatory #J-18808-Ljbffr Vertex Pharmaceuticals
    Senior
    Medical device

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • Katalyst CRO in Boston is seeking a Regulatory Affairs professional to lead CMC strategies for investigational products. The candidate will interact with Health Authorities and manage regulatory submissions to ensure compliance and success. With a foundation in regulatory... 
    Senior

    Katalyst CRO

    Boston, MA
    1 day ago
  • $193k - $210k

    A pharmaceutical firm in Cambridge, MA seeks a Senior Regulatory Affairs Manager to lead the development and execution of regulatory strategies throughout the product lifecycle. Candidates should hold a PhD in health or life sciences, with 6+ years of relevant experience... 
    Senior

    Katalyst CRO

    Boston, MA
    3 days ago
  • $94k - $150k

     ...Senior Regulatory Affairs Specialist The Senior Regulatory Affairs Specialist for Ultrasound collaborates...  ..., Declarations of Conformity, and Medical Device Licensesfor various global markets....  ...changes to existing products. Lead global regulatory intelligence initiatives... 
    Senior
    Medical device
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Cambridge, MA
    1 day ago
  • A leading life sciences company is seeking a Senior Regulatory Affairs Manager to lead their dynamic team through global clinical trials. The role involves driving submission...  ...salary and various benefits including medical insurance and a pension plan. #J-18808-Ljbffr Barrington... 
    Senior
    Remote job

    Barrington James

    Boston, MA
    4 days ago
  • Alnylam Pharmaceuticals is seeking a Senior Manager, Regulatory Affairs CMC Development in Cambridge, MA. In this hybrid position, you will be responsible for implementing the global regulatory CMC strategy, shaping regulatory strategies for innovative modalities like... 
    Senior

    Alnylam Pharmaceuticals

    Cambridge, MA
    3 days ago
  •  ...Incorporated is seeking an Operational Area Quality Senior Manager to provide quality leadership for assembly manufacturing of medical devices and combination products. You will oversee...  ..., change controls, supplier quality, and regulatory compliance. You will collaborate with... 
    Senior
    Medical device

    Vertex Pharmaceuticals Incorporated

    Boston, MA
    4 days ago
  • The Medical Affairs Company (TMAC) is seeking a Senior Medical Science Liaison for a global medical device company, focusing on obstructive sleep apnea. This role involves building relationships with clinicians and supporting product launches. Ideal candidates will have... 
    Senior
    Medical device

    The Medical Affairs Company (TMAC)

    Boston, MA
    3 days ago
  • $100k - $130k

    CPS Inc. in Boston is looking for a Principal Regulatory Specialist responsible for ensuring compliance with FDA and international regulations. You will lead complex compliance programs, provide technical expertise, and manage regulatory risks to protect product integrity... 
    Senior

    CPS Inc.

    Boston, MA
    17 hours ago
  • A medical technology firm in Cambridge, Massachusetts is seeking a seasoned Validation Engineer with over 10 years of experience in...  ...for both new and existing processes, and must be proficient in regulatory compliance with standards such as ISO 13485 and FDA regulations... 
    Senior
    Medical device

    Katalyst CRO

    Cambridge, MA
    3 days ago
  • Parexel is seeking an experienced Senior Regulatory Affairs Consultant in Boston to lead client partnerships and manage sizable outsourcing programs. In this pivotal role, you will employ your Regulatory Affairs expertise to deliver tailored solutions, drive projects,... 
    Senior

    Parexel

    Boston, MA
    3 days ago
  • Job Title: Senior Manager, Regulatory Affairs Advertising and Promotion Location: Morristown...  ...serving as regulatory lead for product launches. As...  ...Committees (RC) for commercial and medical materials, respectively....  ...pharmaceutical or medical device advertising and... 
    Senior
    Medical device
    Work experience placement

    Eacademy Sanofi

    Cambridge, MA
    3 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Regulatory Affairs Lead - Medical Devices. Be the first to apply!