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

Senior Director, Clinical Affairs — FDA-Regulated Devices

Eight Sleep, Inc.

Eight Sleep, Inc. is seeking a Director of Clinical Affairs to own end-to-end regulatory-driven clinical studies. This hands-on role requires building studies from scratch, managing sites, preparing IRB/ICFs, and overseeing data management and study committees to ensure on-time, on-budget execution. You will bridge internal teams with investigators, CROs, IRBs, and regulatory agencies, bringing fluency in FDA device regulations and ICH-GCP to drive regulatory submissions and audits. #J-18808-Ljbffr Eight Sleep, Inc.

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Director, Clinical Affairs — FDA-Regulated Devices in Boston, MA vacancy
  •  ...A medical device company in Cambridge, MA, is seeking a Regulatory Affairs professional to lead regulatory strategies for Class...  ...Responsibilities include managing FDA submissions, ensuring...  ...affairs, strong knowledge of FDA regulations, and a relevant degree. This position... 
    Senior

    Medella Life

    Cambridge, MA
    3 days ago
  • $200k - $250k

     ...The RoleWe're looking for a Director of Clinical Affairs who will own the end-to-end...  ..., DSMB, etc.), prepare for FDA submissions and audits, and...  ...requirements for medical devices, and you'll have a track record...  ...Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 8... 
    Suggested
    Full time
    Contract work
    Immediate start
    Worldwide
    Night shift

    Eight Sleep

    Boston, MA
    4 days ago
  •  ...and advocacy groups in all of our clinical and regulatory development strategies...  ...’ lives. About the role The Senior Director, Global Medical Affairs will report to the VP, Medical...  ...policies, legal standards, and industry regulations. Qualifications Advanced... 
    Senior
    Local area
    Flexible hours

    Zevra Therapeutics, Inc.

    Boston, MA
    1 day ago
  • $171k - $273k

    Job TitleDirector, Clinical Affairs of Coronary/...  ...Coronary/VascularThe Director, Clinical Affairs...  ...with applicable regulations, standards, and company...  ...function in senior leadership,...  ...within the medical device industry, and 5+...  ...multiple regions, FDA medical device regulations... 
    Suggested
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Cambridge, MA
    4 days ago
  • A healthcare technology company is seeking a Sr. Regulatory Affairs Specialist in Somerville, Massachusetts, to support the commercialization...  ...input on product development, maintaining compliance with FDA regulations, and preparing regulatory submissions. Ideal candidates will... 
    Senior
    Remote job

    Hmixray

    Somerville, MA
    3 days ago
  • We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. This is a hands-on, operationally intense...  ...Ensure compliance with FDA regulations (21 CFR Parts 11, 50, 56, 812, 8... 
    Contract work

    BioTalent

    Boston, MA
    2 days ago
  • $344k - $380.4k

     ...dedicated to drug discovery, clinical development, and...  ...The Role We are seeking a Senior Medical Director, Clinical Development to...  ...Operations, Regulatory, Medical Affairs and Commercial. Provide...  ...Practices (GCP), FDA and EMEA/CHMP regulations and guidelines, and applicable... 
    Senior
    Temporary work
    Remote work
    2 days per week

    Xenon Pharmaceuticals Inc.

    Boston, MA
    4 days ago
  • $220k - $240k

     ...grow your career in science, clinical development, commercial...  ...the function within Medical Affairs (MA). This senior leader will be responsible...  ...data protection regulations. Serves as the primary MI...  ...or equivalent) required. Director level: 10 years of experience... 
    Senior
    Worldwide
    Flexible hours

    Vor Bio

    Boston, MA
    2 days ago
  • $143k - $191k

    About This Role The Senior Medical Manager is a part of the US Medical...  ...Hematology Associate Medical Director, the Senior Medical Manager...  ...Legal/Compliance, Regulatory Affairs and Commercial) from the US...  ...(eg, Global Medical, Clinical Development, Medical Evidence... 
    Senior
    Full time
    Temporary work
    Local area

    Biogen Idec

    Cambridge, MA
    2 days ago
  • $223.2k - $334.8k

    Medical Affairs Science Senior Director - PainSkip to main content#Medical Affairs Science Senior Director - Pain page is loaded## Medical Affairs...  ...within disease area and ensure new information to transform clinical trends and emerging data is integrated into medical plans... 
    Senior
    Summer work
    Remote work
    Flexible hours
    2 days per week

    Vertex Pharmaceuticals

    Boston, MA
    1 day ago
  • $220k - $290k

     ...treatment resistance. The FDA approval of AVMAPKI...  ...resistance. With clinical trials underway, we...  ...‑term plans. The Senior Director, Regulatory Affairs has foresight, is action...  ..., biologics and devices) development, registration...  ..., product specific regulator advice, and other... 
    Senior
    Temporary work
    For contractors
    Work at office
    Weekday work

    Verastem

    Boston, MA
    2 days ago
  • $268k - $302k

     ...Senior Director, Clinical PharmacologyCambridge, MA - RemoteAmylyx has an audacious...  ..., Biometrics, Regulatory Affairs, Translational Medicine,...  ...submissions and interacting with FDA and other global health...  ...insurance coverage and state tax regulations, we are unable to hire... 
    Senior
    Local area
    Remote work

    Amylyx Pharmaceuticals Inc

    Cambridge, MA
    1 day ago
  •  ...Vertex Pharmaceuticals is looking for a Senior Director in Medical Affairs Science, located in Boston, MA. This critical role involves developing the Medical Plan for the Pain disease area, leading medical reviews, and engaging with thought leaders. The ideal candidate... 
    Senior
    Remote job

    Jobleads-US

    Boston, MA
    3 days ago
  •  ...within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute...  ...project teams throughout clinical development and commercial lifecycle...  ...of global RA CMC regulations and guidelines and can apply this... 
    Senior

    Katalyst Healthcares & Life Sciences

    Boston, MA
    18 hours ago
  •  ...Senior Manager, Clinical Trials Job Location: Irvine, USA | SanFrancisco...  ...execution of device studies required for...  ...functionally with Medical Affairs, Clinical Development...  ...GCP guidelines/regulations and applicable SOPs...  ...local mandates like FDA regulations, ICG-GCP,... 
    Senior
    Temporary work
    Local area
    Flexible hours

    Bausch Health

    Boston, MA
    5 days ago
  • $274.4k - $411.6k

     ...of Boston, Massachusetts.Summary The Senior Director, Clinical Development will provide medical and...  ...serve as a key partner to investigators, regulators, and senior leadership. This highly...  ...Pharmacology, Biometrics, Regulatory Affairs, Drug Safety, Data Management,... 
    Senior

    Tango Therapeutics

    Boston, MA
    2 days ago
  • Vertex Pharmaceuticals is seeking a Senior Director or Medical Affairs Director in Boston, MA to oversee global activities in the Pain disease area. The candidate will be responsible for medical plan development, strategy execution, and engaging with key thought leaders... 
    Senior

    Vertex Pharmaceuticals

    Boston, MA
    5 days ago
  • $235k - $330k

    Who we are:Kymera is a clinical-stage biotechnology company pioneering...  ...you’ll make an impact:The Senior Director, Clinical Operations is a...  ...including ICH GCP and local regulations)Develop and manage comprehensive...  ...Development, Regulatory Affairs, Biostatistics and Program Leadership... 
    Senior
    Local area

    Kymera Therapeutics

    Watertown, MA
    2 days ago
  • A leading biotechnology company seeks a Medical Affairs Senior Medical Director in Boston to provide scientific leadership in Nephrology. Responsibilities include developing medical affairs plans, ensuring patient access to therapies, and collaborating with global teams... 
    Senior

    Vertex Pharmaceuticals (San Diego) LLC

    Boston, MA
    5 days ago
  • $10k

     ...communication consistency. Coordinate with Legal/Compliance, Regulatory Affairs, and Commercial to ensure medical soundness, compliance, proper...  ...development as assigned. Coordinate with Global Medical, Clinical Development, Medical Evidence Generation Clinical Operations,... 
    Senior
    Temporary work

    Scorpion Therapeutics

    Cambridge, MA
    1 day ago
  • $143k - $191k

     ...About This Role The Senior Medical Manager is a part of the US...  ...Hematology Associate Medical Director, the Senior Medical Manager will...  ...Legal/Compliance, Regulatory Affairs and Commercial) from the US...  ...(eg, Global Medical, Clinical Development, Medical Evidence... 
    Senior
    Full time
    Temporary work
    Local area

    Biogen

    Cambridge, MA
    13 days ago
  • $175k - $195k

     ...Senior Director, Clinical OperationsSkip to main contentYou may choose to display a cookie banner...  ...Nonclinical Development, Regulatory Affairs, Quality Assurance, Manufacturing/CMC...  ...with GCP, GLP, GMP, ICH guidelines, FDA regulations, and other applicable global regulations... 
    Senior
    Contract work

    Alira Health Group

    Boston, MA
    2 days ago
  • $262.06k - $306.73k

     ...medication approved by both the FDA and European Commission for...  ..., in the right way. The Senior Director, Clinical Operations provides...  ...EMA, and applicable regional regulations. Lead CRO selection, contracting...  ...Development, Regulatory Affairs, Data Management, Project and... 
    Senior
    Minimum wage
    Full time
    Local area
    Flexible hours

    Madrigal Pharmaceuticals Inc

    Waltham, MA
    58 minutes ago
  • $285k - $305k

    Alkermes seeks a Senior Medical Director for Pipeline in Boston to lead medical affairs for early and mid-stage development compounds. This high-visibility role requires an advanced science/medical degree and a minimum of 5 years' experience in the biopharmaceutical industry... 
    Senior

    Alkermes

    Boston, MA
    5 days ago
  • $266k - $344k

    Beeline Medicines is seeking a Medical Director in Boston to lead medical affairs for autoimmune diseases, particularly lupus. This role involves driving...  ...scientific expertise, experience in managing lupus clinical programs, and a strong KME network. A hybrid work schedule... 
    Senior
    2 days per week

    Beeline Medicines

    Boston, MA
    5 days ago
  • Title:Senior Medical Director, Global Medical Affairs - Neurosciences (Migraine Lead) Company:Ipsen Biopharm Ltd About Ipsen Ipsen is a mid-sized global biopharmaceutical...  ...excellence. Oversee the design and implementation of clinical and real-world evidence generation plans specific to... 
    Senior

    Ipsen Biopharm Ltd

    Cambridge, MA
    2 days ago
  •  ...Pharmaceuticals is seeking an Executive Medical Director, Clinical Development to shape and lead clinical...  .... You will collaborate with Medical Affairs, Regulatory, R&D, and Commercial...  ...a track record of interacting with regulators. #J-18808-Ljbffr Vertex Pharmaceuticals
    Senior

    Vertex Pharmaceuticals

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

     ...TitleSenior Regulatory Affairs SpecialistJob...  ...Specialist, UltrasoundThe Senior Regulatory Affairs...  ...such as the FDA, Health Canada, EU...  ...guidance on clinical studies and evaluations...  ..., and Medical Device Licenses—for various...  ...understanding of relevant regulations and standards (FDA... 
    Senior
    Full time
    Work at office
    Immediate start
    Work visa
    Relocation package
    3 days per week

    Philips

    Cambridge, MA
    3 days ago
  • BioTalent is seeking a Director of Clinical Affairs to own end-to-end execution of regulatory-driven clinical studies for a growing medical device company. The role is hands-on and operationally...  ...product, and legal teams to enable FDA clearances and market success. #J-... 

    BioTalent

    Boston, MA
    2 days ago
  • $180k - $200k

     ...About The Role You'll be the first Clinical hire in the US, leading a team...  ...clinical budget, and represent Clinical Affairs at Excom Own the clinical case for FDA 510(k) and EU MDR submissions,...  ...in Clinical Affairs at a medical-device company, ideally in AI / SaMD; healthtech... 
    Remote work
    Worldwide
    Flexible hours

    OneRagtime

    Boston, MA
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Director, Clinical Affairs — FDA-Regulated Devices. Be the first to apply!