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

Senior Regulatory Affairs Lead - IVD & Medical Devices

$124k - $152k

Caris Life Sciences

Caris Life Sciences is seeking a Manager - Regulatory Affairs in Boston, MA. The role involves leading regulatory strategies for in vitro diagnostic projects. This includes preparing regulatory documents, ensuring compliance, and guiding project teams on regulatory matters. Candidates should possess a Bachelor’s degree in a science-related field, with at least 6 years of regulatory submission experience in medical devices or IVDs. The position involves collaboration with pharmaceutical partners and possibly leading FDA submissions. Competitive annual salary between $124,000 and $152,000 is offered. #J-18808-Ljbffr Caris Life Sciences

Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Senior Regulatory Affairs Lead - IVD & 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
    2 days ago
  • $147.76k - $203.17k

    Dormont Manufacturing Co is seeking a Regulatory Affairs Professional for their hybrid role in...  ...include ensuring compliance with FDA and IVD regulations and collaborating with...  ...and at least two years of experience in medical devices or IVDs are required. This position offers... 
    Medical device

    Dormont Manufacturing Co

    Walpole, 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
    4 days ago
  • Haemonetics is seeking an experienced Senior Biomedical Product...  ...of components for the TEG6s IVD system, influencing clinical...  ...decision‑making globally. You will lead the development lifecycle,...  ...experience, particularly in medical devices and disposable components. #J... 
    Senior
    Medical device

    haemonetics

    Boston, 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
    3 days 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
    1 day 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
    2 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
    1 day 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
    1 day 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
    1 day 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
    2 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
    1 day 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
    14 hours ago
  •  ...Corp in Boston, MA is seeking a Senior Biomedical Product Development Engineer to lead the mechanical design of disposable components for the TEG6s IVD system. This role is vital for ensuring...  ...least 5 years of experience in medical device development, a strong background... 
    Senior
    Medical device

    Haemonetics Corp

    Boston, MA
    1 day 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
    1 day ago
  • $238k - $374k

    Initial Therapeutics, Inc. is looking for an Executive Director of Global Regulatory Affairs in Boston, MA. This role entails leading a team to oversee the regulatory strategy for medical devices and drug-device combination products. The successful candidate will have 2... 
    Medical device

    Initial Therapeutics, Inc.

    Boston, 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
    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
    2 days 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
    2 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
    1 day 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
    1 day 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
    2 days ago
  •  ...Corporation is seeking a Statistical Programming Lead to provide strategic and operational...  ...(Phase I-III). You will ensure timely, regulatory-compliant deliverables and partner with...  ...Biostatistics, Data Management, Regulatory Affairs, and external providers. The role reports... 
    Senior

    Orion Corporation

    Boston, MA
    2 days 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
    1 day 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
    1 day 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
    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
    2 days ago
  • Initial Therapeutics, Inc. in Cambridge, Massachusetts is looking for a Regulatory Affairs Specialist focused on planning and supporting regulatory inspections. The role involves ensuring compliance with Health Authority Regulations through various activities such as planning... 
    Senior

    Initial Therapeutics, Inc.

    Cambridge, MA
    14 hours 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
    1 day 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
    3 days ago

Do you want to receive more vacancies?

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