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.
- ...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
$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...SuggestedFull timeContract workImmediate startWorldwideNight shift- ...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...SeniorLocal areaFlexible hours
$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...SuggestedFull timeWork at officeImmediate startWork visaRelocation package3 days per week- 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...SeniorRemote job
- 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
$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...SeniorTemporary workRemote work2 days per week$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...SeniorWorldwideFlexible hours$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...SeniorFull timeTemporary workLocal area$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...SeniorSummer workRemote workFlexible hours2 days per week$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...SeniorTemporary workFor contractorsWork at officeWeekday work$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...SeniorLocal areaRemote work- ...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...SeniorRemote job
- ...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
- ...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,...SeniorTemporary workLocal areaFlexible hours
$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- 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
$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...SeniorLocal area- 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
$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,...SeniorTemporary work$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...SeniorFull timeTemporary workLocal area$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...SeniorContract work$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...SeniorMinimum wageFull timeLocal areaFlexible hours$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$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...Senior2 days per week- 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
- ...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 PharmaceuticalsSenior
$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...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- 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-...
$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 workWorldwideFlexible hours
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