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  • £42k - £56k per annumEstimated
     ...InterSystems TrakCare seeks product leaders with clinical and/or health...  ..., public health, IoT devices, patient self-care and outcomes...  ...development partners. The Product Specialist utilizes health domain...  ...as an internal subject matter expert in one or more health domain areas... 
    Regulatory
    Worldwide

    InterSystems

    USA
    2 days ago
  • £61k - £80k per annumEstimated
     ...Fit We're looking for an experienced product manager to join our team and help support...  ...science, clinical affairs, quality, regulatory, and business operations teams to ensure...  ...field preferred ~ Experience working with medical devices (SaMD) high preferred. ~ Knowledge and... 
    Regulatory
    Medical device

    PathAI

    USA
    2 days ago
  • $131.4k - $197.1k per annum

     ...Insulet Corporation is an innovative medical device company dedicated to simplifying the lives...  ...and healthier lives using our Omnipod® product platform. In the last two decades we have...  ...project direction. Act as the medical expert, drawing on your experience and knowledge... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Work at office
    Remote work
    Hybrid work

    Insulet Corporation

    USA
    10 days ago
  • £62k - £81k per annumEstimated
    Position: Clinical, Regulatory, and Quality Manager ??"?Location: Boston, MA (Onsite)...  ...Managing design documentation control for product development ??"? Leading quality audits...  ..., Regulatory, and Quality roles within medical devices or healthtech ? Strong knowledge of FDA... 
    Regulatory
    Medical device
    Full time

    Cedent

    USA
    10 days ago
  • £39k - £51k per annumEstimated
     ...Responsibilities: This position is responsible for the preparation of regulatory submissions required to market medical devices in both the U.S. and Europe, support of international product registrations and related regulatory affairs activities, including execution of... 
    Regulatory
    Medical device
    Full time

    Katalyst HealthCares and Life Sciences

    USA
    2 days ago
  • £40k - £52k per annumEstimated
     ...change assessments for US Class II devices to ensure compliance with the...  ...ensure compliance with the EU Medical Device Regulation. Plan and...  ...submission and maintenance of product registrations in markets...  ...compiling documents for submission to regulatory authorities, as well as... 
    Regulatory
    Medical device
    Full time
    Worldwide
    Hybrid work

    Cedent

    USA
    2 days ago
  • £56k - £75k per annumEstimated
    Lexington Medical is a medical device company, developing and manufacturing minimally invasive surgical stapling solutions in the Boston...  ...thrive in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and execute a regulatory strategy for... 
    Regulatory
    Medical device
    Full time
    Worldwide

    Lexington Medical

    USA
    2 days ago
  • £33k - £43k per annumEstimated
     ...role includes obtaining and maintaining regulatory approvals, supporting quality management...  ...Affairs position is responsible for global product registrations and ensuring regulatory...  ...the design, manufacturing, and sales of medical devices (including Class I and II devices, software... 
    Regulatory
    Medical device
    Full time
    Long term contract

    Katalyst HealthCares and Life Sciences

    USA
    2 days ago
  • £40k - £53k per annumEstimated
    Regulatory Affairs Specialist Location: Marlborough, Massachusetts Do you have a proven track record of working with Regulations and the implementation of labeling for Medical Device UDI project? Do you want to work on a fantastic team as they undergo the changes for the... 
    Regulatory
    Medical device

    The CERES Group

    USA
    2 days ago
  • £52k - £69k per annumEstimated
     ...Senior Director/Director of Regulatory Affairs , based in our Andover...  ...revolutionize this cutting-edge medical field. If you are looking for...  ...Engineering teams on changes to products and manufacturing processes...  ...complaint review and Medical Device reporting Serve as regulatory... 
    Regulatory
    Medical device
    Permanent employment
    Full time

    TransMedics

    USA
    10 days ago
  • £99k - £131k per annumEstimated
     ...Description About the Job The VP, Regulatory Affairs and Quality Assurance will be a...  ...functionally with Global Laboratory Operations, Product Development, Marketing, Manufacturing,...  ...laboratory-developed tests, diagnostics medical device products, and/or therapeutics... 
    Regulatory
    Medical device

    Foundation Medicine, Inc.

    USA
    2 days ago
  • $147k - $212.33k per annum

     ...Join our Biostatistics team as a Safety Expert Statistician and you'll be supporting...  ...to external stakeholders (e.g. regulatory authorities, medical journals), and scientific validity....  ...mentoring to junior staff. Ensure productive collaborations with other functions in... 
    Regulatory
    Permanent employment
    Full time
    Hybrid work

    Sanofi

    USA
    2 days ago
  • £50k - £66k per annumEstimated
     ...Position Summary: The Director, Regulatory Affairs manages, evaluates and...  ...for drugs, biologics and devices. Ensures regulatory submissions...  ...Experience with drugs, biologics and/or medical devices ~ Previous experience with combination products and/or botanicals a plus ~... 
    Regulatory
    Medical device
    For contractors
    Work at office
    Remote work
    Monday to Thursday

    Vericel

    USA
    2 days ago
  • £44k - £59k per annumEstimated
     ...of their bodies and daily lives. WHOOP is seeking a Regulatory Affairs Manager (Medical Devices) to navigate and manage regulatory affairs for Medical...  ...collaborating with the WHOOP Medical Device Team throughout the product development process, and ensuring compliance with the... 
    Regulatory
    Medical device
    Work at office
    Relocation

    Whoop

    USA
    2 days ago
  • £85k - £111k per annumEstimated
     ...lead clinical development efforts, oversee regulatory pathways, and collaborate closely with...  ...Provide clinical expertise to support product development, guiding the integration of...  ...experience in clinical research and trials for medical devices, preferably with experience of critical... 
    Regulatory
    Medical device
    Permanent employment
    Full time

    CoMind Technologies Limited

    USA
    2 days ago
  • £33k - £43k per annumEstimated
     ...efficiently and responsibly resolve complex natural resource, digital, energy transition and infrastructure challenges. Product Marketing Specialist Location: [Insert Location or Hybrid] Department: Business Marketing Company: Viridien Viridien is seeking a Product... 
    Full time
    Hybrid work

    Viridien

    USA
    5 days ago
  • £60k - £79k per annumEstimated
     ...clinical trials, ensuring alignment with regulatory timelines and study objectives....  ...inform go-to-market strategies, including product positioning, pricing, launch planning, and...  ...within the pharmaceutical, biotech, or medical device sectors. ~ Proven success in clinical... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Long term contract

    Briohealth Solutions, Inc.

    USA
    2 days ago
  • £47k - £61k per annumEstimated
     ...Job Description About the Job The Regulatory Affairs Manager is responsible for...  ...other regulatory authorities) for FMI products. The incumbent functions as the regulatory...  ...approval of in vitro companion diagnostic medical devices in the US market. • Develop... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Hybrid work

    Foundation Medicine, Inc.

    USA
    2 days ago
  • £51k - £68k per annumEstimated
     ...our in vitro diagnostic (IVD) device projects and validation strategies...  ...results, and contributing to regulatory submissions. The ideal...  ...will have strong scientific and medical knowledge, experience with regulated...  ...with the clinical, product, biostats and regulatory teams... 
    Regulatory
    Medical device

    PathAI

    USA
    2 days ago
  • $89.4k - $134.1k per annum

    The Senior Regulatory Affairs Specialist will lead activities which support both domestic and international...  ...including working with Marketing, New Product Development, Manufacturing and...  ...initiatives to ensure regulatory approval of medical devices in both domestic and... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Work at office
    Hybrid work
    3 days week

    Insulet Corporation

    USA
    10 days ago
  • $122.7k - $184.05k per annum

     ...play a critical role in leading the team and providing expert statistical support for internally sponsored, real-...  ...statistical methodologies, sample size calculations, and regulatory requirements within the medical device industry. The position requires strong leadership... 
    Regulatory
    Medical device
    Full time
    Work at office
    Remote work
    Hybrid work

    Insulet Corporation

    USA
    2 days ago
  • £59k - £78k per annumEstimated
     ...role combines subject matter expertise, regulatory-savvy strategy, and hands-on leadership...  ...WHOOP generate the evidence required for product development, regulatory submissions, and...  ...and deep experience in digital health, medical device development, or pharmaceutical trials.... 
    Regulatory
    Medical device
    Long term contract
    Work at office
    Relocation

    Whoop

    USA
    2 days ago
  • $172.5k - $249.17k per annum

     ...Job Title: Director, US Regulatory Affairs - Advertising and Promotion...  ...to-day activities for assigned products, departmental activities, and...  ...functions as the therapeutic product expert for Region NA, A&P....  ...experience within pharmaceutical or medical device Regulatory Affairs ~... 
    Regulatory
    Medical device
    Permanent employment
    Full time

    Sanofi

    USA
    2 days ago
  • $103.7k per annum

     ...pivotal study program based on an innovative medical device technology platform. The Senior FCE will...  ...for all aspects of case support and product education aimed at treating product...  ...developments in field(s) of expertise, regulatory requirements, and working knowledge of company... 
    Regulatory
    Medical device
    Hourly pay
    Long term contract
    Visa sponsorship
    Remote work
    Worldwide
    Work visa

    Boston Scientific

    USA
    2 days ago
  • £42k - £55k per annumEstimated
     ...contribute to the development of groundbreaking medical device technologies that transform patient care...  ...quality clinical evidence that supports regulatory clearance, market adoption, and business...  ...of clinical evidence to support product positioning and market expansion. Collaborate... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Remote work

    Hologic

    USA
    2 days ago
  • $174.6k - $261.9k per annum

     ...partnership by driving clinical strategy, ensuring regulatory compliance, and generating strong clinical evidence to support product development, regulatory submissions, and...  ...position requires a deep understanding of medical device regulations. In addition, the position... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Work at office
    Remote work
    Hybrid work

    Insulet Corporation

    USA
    10 days ago
  • £49k - £65k per annumEstimated
     ...Key managerial position for Quality, Regulatory and Clinical activities in support of the...  ...monitoring, and controlling In Vitro Diagnostic medical devices' entire clinical evaluation process. The...  ...Strategic Activities: Subject Matter Expert in in all matters relating to clinical... 
    Regulatory
    Medical device
    Long term contract
    Local area

    Waters Corporation

    USA
    2 days ago
  • $99.3k - $148.95k per annum

     ...Department: Clinical and Medical Affairs FLSA Status: Exempt...  ...well as assuring compliance with regulatory and quality procedures and standards...  ...according to medical device regulations, as well as human...  ...the approval/clearance of new products. Manages all aspects of product... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Work at office
    Remote work
    Hybrid work
    Flexible hours

    Insulet Corporation

    USA
    2 days ago
  • $119.67k - $167.54k per annum

     ...philosophy, True to Life, by advancing medical technologies and elevating the...  ...Assist the Manager, Regulatory Affairs in obtaining approval to market Olympus medical devices in the markets served by Olympus...  ...market segments, that lead to product teams responsible for... 
    Regulatory
    Medical device
    Full time
    Local area
    Remote work
    Worldwide
    Hybrid work

    Olympus Corporation of the Americas

    USA
    2 days ago
  • £30k - £39k per annumEstimated
     ...functional team members in scientific and clinical affairs, product development, regulatory, quality, and manufacturing. Essential Functions: •...  ...make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... 
    Regulatory
    Medical device
    Permanent employment
    Full time
    Worldwide

    ZOLL Medical Corporation

    USA
    10 days ago