Jobs
>
Cambridge

    Sr. Manager Regulatory Affairs - Cambridge, MA, United States - Philips

    Philips
    Philips Cambridge, MA, United States

    4 weeks ago

    Default job background
    Description
    Job TitleSr. Manager Regulatory Affairs

    Job Description

    The Senior Manager Regulatory Affairs will play a critical role within Philips' Clinical Informatics organization by leading regulatory projects for Philips' Disease Management Solution products, ensuring and maintaining global accurate regulatory strategy and market access, directly impacting the lives of patients around the world.

    Your role:

    • Leading project teams for end-to-end regulatory affairs input and deliverables for new product introductions and product changes across the globe.
    • Through end-to-end regulatory processes, ensuring safe and effective products / solutions are brought to market, on time, and sustained throughout life cycle via compliant, innovative regulatory strategies.
    • Provide critical input on regulatory risk assessments to support portfolio selection.
    • Collaborate and extend in proactive, strategic relationships with external stakeholders (Notified Bodies, FDA, Competent Authorities, and other Regulatory bodies) to ensure that requirements are known early during strategy development, enabling rapid market access with the current portfolio in connection with future innovations.
    • Building FDA regulatory submissions strategy for the products portfolio, providing related guidance to cross functional dedicated team and authoring 510K submissions.
    • Leading and enabling strong cross-functional partnership between Regulatory Affairs and all key stakeholders including R&D, Marketing, Quality, Clinical Affairs, and other functions at all levels within the business, and the local Regulatory Affairs teams in the Philips international markets organization.
    • This Hybrid role may require travel up to 10%.

    You're the right fit if:

    • You have a minimum of 10 years' experience in FDA Regulated Medical Device/HealthTech environments, with extensive knowledge and experience authoring 510K's, PMA's, Pre-submissions, IDE, Technical Files/Design Dossiers, and other regulatory submissions.
    • You have 5 years' experience leading product development teams in satisfying registration requirements to bring products to market on time.
    • You have detailed knowledge of MDD/MDR, MedDev's, FDA QSR's, FDA SaMD related and cybersecurity guidance's, ISO 13485, ISO 14971, IEC 62304, and applicable medical device regulations/standards for the EMEA market, including SaMD.
    • You have practical knowledge and experience with Advanced Visualization SaMD for diagnosis support (highly desired).
    • You have proven experience building strategic relationships with external stakeholders (e.g., Notified Bodies, FDA, Competent Authorities).
    • You have experienced formulating and implementing global regulatory strategies to ensure compliance with worldwide regulations to improve product market access.
    • You're an excellent communicator and collaborator who can build and maintain cross-functional partnerships in support of business successes.
    • You're self-directed with a strong work ethic and with an ability to work in a goal-oriented environment.
    • You have a minimum of a Master's degree (REQUIRED), preferably in Regulatory Affairs or a Life Sciences field.
    • You must be able to successfully perform the following minimum Physical, Cognitive and Environmental job requirements with or without accommodation for this position .
    • US work authorization is a precondition of employment. The company will not consider candidates who require sponsorship for a work-authorized visa, now or in the future.

    About Philips:

    We are a health technology company. We built our entire company around the belief that every human matters, and we won't stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help improve the lives of others.

    • Learn more about our business.
    • Discover our rich and exciting history.
    • Learn more about our purpose.
    • Read more about our employee benefits.

    If you're interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion here.

    Philips Transparency Details:

    The pay range for this position is $104,000 to $178,000, annually. The actual base pay offered may vary depending on multiple factors including, job-related knowledge/skills, experience, business needs, geographical location, and internal equity.

    #LI-PH1

    This requisition is expected to stay active for 45 days but may close earlier if a successful candidate is selected or business necessity dictates. Interested candidates are encouraged to apply as soon as possible to ensure consideration.

    Philips is an Equal Employment and Opportunity Employer/Disabled/Veteran and maintains a drug-free workplace.

    PDN-9c0fbf55-f967-48cb-b d4418a58
  • Philips

    Regulatory Affairs Specialist

    2 weeks ago

    Philips Cambridge, United States Full time

    JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...

  • Philips

    Regulatory Affairs Specialist

    3 weeks ago

    Philips Cambridge, United States Full time

    JOB DESCRIPTION Job Title · Regulatory Affairs Specialist Job Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards cre ...

  • Relay Therapeutics

    Director, Regulatory Affairs

    5 days ago

    Relay Therapeutics Cambridge, United States

    The Opportunity: · We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. Yo ...

  • Philips

    Regulatory Affairs Specialist

    2 weeks ago

    Philips Cambridge, United States Full time

    Job Title · Regulatory Affairs SpecialistJob Description · Looking at the challenges the world is facing today Philips' purpose has never been more relevant. So, whatever your role, if you share our passion for helping others, you'll be working towards creating a better and faire ...

  • Korro Bio, Inc.

    VP Regulatory Affairs

    1 week ago

    Korro Bio, Inc. Cambridge, United States

    Korro is a biopharmaceutical company focused on developing a new class of genetic medicines for both rare and highly prevalent diseases using its proprietary RNA editing platform. Korro is generating a portfolio of differentiated programs that are designed to harness the body's n ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Manager

    1 week ago

    Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: · However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requiremen ...

  • Katalyst HealthCares & Life Sciences

    Regulatory Affairs Manager

    3 weeks ago

    Katalyst HealthCares & Life Sciences Cambridge, United States

    Responsibilities: However, they will mainly fall within the areas of Pharmaceutical, Biotechnology or Biologics Regulatory Affairs · This individual will prepare, compile, and submit CT/IND/MAA I NOA, manage and implement label review, translation requirements, fee requirements ...

  • Third Rock Ventures

    Regulatory Affairs

    3 days ago

    Third Rock Ventures Waltham, United States

    The position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...

  • Third Rock Ventures

    Regulatory Affairs

    1 week ago

    Third Rock Ventures Waltham, United States

    The position will provide regulatory expertise and leadership to assure that the company meets its business objectives while complying with the regulatory framework by taking into account applicable laws, regulations and guidance documents. The incumbent will be responsible for i ...

  • WHITE COLLAR TECHNOLOGIES INC

    Regulatory Affairs Associate

    4 weeks ago

    WHITE COLLAR TECHNOLOGIES INC Boston, United States

    Job Description · Job DescriptionJob Description · We have multiple openings for Life Science Quality Assurance Analysts, Regulatory Affairs Specialist, and Quality Control Analysts. All of these roles will interface with clients on different projects to provide consulting servic ...

  • Compass Therapeutics

    VP of Regulatory Affairs

    2 days ago

    Compass Therapeutics Boston, United States

    Job Description · Job DescriptionCompass Therapeutics, Inc. is a clinical-stage, oncology-focused biopharmaceutical company developing proprietary antibody-based therapeutics to treat multiple human diseases. Compass' scientific focus is on the relationship between angiogenesis, ...

  • SpringWorks Therapeutics

    Regulatory Affairs Director

    6 days ago

    SpringWorks Therapeutics Boston, United States

    Job Description · Job DescriptionAbout SpringWorks Therapeutics: · SpringWorks is a commercial-stage biopharmaceutical company applying a precision medicine approach to developing and delivering life-changing medicines for people with severe rare diseases and cancer. · SpringWork ...

  • RBW Consulting

    Senior Director Regulatory Affairs

    2 weeks ago

    RBW Consulting Cambridge, United States

    RBW is partnering with an innovative late clinical-stage, oncology Biotech (140 FTE) in their urgent and business-critical search for a new Senior Director, Regulatory Affairs. Our client is focused on discovering and developing precision medicines for the treatment of autoimmune ...

  • Vigil Neuroscience, Inc.

    VP, Regulatory Affairs

    4 weeks ago

    Vigil Neuroscience, Inc. Watertown, United States

    Job Description · Job DescriptionVigil Neuroscience is the world's first microglia-focused therapeutics company. Our purpose is clear: to treat rare and common neurodegenerative diseases by restoring the vigilance of the microglia, the sentinel cells of the brain's immune system. ...

  • Bicycle Therapeutics

    Associate Director, Regulatory Affairs

    5 days ago

    Bicycle Therapeutics Cambridge, United States

    Job Description · Job DescriptionCompany Description · Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are ful ...

  • Bicycle Therapeutics Limited

    Associate Director, Regulatory Affairs

    3 days ago

    Bicycle Therapeutics Limited Cambridge, United States

    Company Description · Bicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides cons ...

  • Sanofi Group

    Global Regulatory Affairs Lead

    4 days ago

    Sanofi Group Cambridge, United States

    Sanofi Group · Global Regulatory Affairs Lead · Cambridge , · Massachusetts · Apply Now · Job title: Global Regulatory Affairs Lead · Location: Cambridge, MA or Bridgewater, NJ · About the job · The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker ...

  • Editas Medicine

    Senior Manager, Regulatory Affairs

    2 weeks ago

    Editas Medicine Cambridge, United States Permanent

    At Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRI ...

  • National Black MBA Association

    Principal Regulatory Affairs Specialist

    4 days ago

    National Black MBA Association Cambridge, United States

    Job TitlePrincipal Regulatory Affairs SpecialistJob Description · Principal Regulatory Affairs Specialist- Software & Artificial Intelligence (U.S. Hub Based) · The Principal Regulatory Affairs Specialist- SW & AI will shape, lead and execute innovative regulatory strategies to ...

  • Takeda Development Center Americas, Inc

    Manager, Regulatory Affairs CMC

    3 weeks ago

    Takeda Development Center Americas, Inc Cambridge, United States

    Takeda Development Center Americas, Inc. is seeking a Manager, Regulatory Affairs · CMC in Cambridge, MA to Develop the Global Regulatory Strategy for products in commercial and development phase; ensure timely submission of new submissions (IND, NDA, BLA, JNDA) to various Globa ...