Director, Clinical Trials for Medical Devices & SaMD
BioTalent
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 intensive, requiring leadership across design, execution, and post-market surveillance for devices and SaMD. You will drive study design, timelines, budgets, and compliance, collaborating with regulatory, product, and legal teams to enable FDA clearances and market success. #J-18808-Ljbffr BioTalent
$200k - $250k
...The RoleWe're looking for a Director of Clinical Affairs who will own the... ...regulatory requirements for medical devices, and you'll have a track record... ...committees to ensure trials lead to successful clearance... ...ISO 14155, and applicable SaMD guidance documents.Manage relationships...Medical deviceFull timeContract workImmediate startWorldwideNight shift- WHOOP is seeking a Director, Clinical Science, to lead clinical development efforts focused on Software as a Medical Device (SaMD). You will oversee clinical strategy throughout the product lifecycle, ensuring the evidence supports regulatory compliance and business goals...Medical device
$210k - $230k
As the Director, Clinical Operations, you will lead the clinical operations function responsible... ...a particular focus on Software as a Medical Device (SaMD). You will own operational strategy... ...requires deep expertise in clinical trial operations, decentralized clinical trials...Medical deviceFull timeWork at officeRemote workRelocation- ...deeper understanding of their bodies and daily lives. As the Director, Clinical Science, you will lead the clinical science function... ...health features, with a particular focus on Software as a Medical Device (SaMD). You will own clinical strategy across the product lifecycle...Medical device
$220k - $245k
...deeper understanding of their bodies and daily lives.As the Director, Clinical Science, you will lead the clinical science function... ...health features, with a particular focus on Software as a Medical Device (SaMD). You will own clinical strategy across the product lifecycle...Medical deviceFull timeWork at officeRemote workRelocation$171k - $273k
Job TitleDirector, Clinical Affairs of Coronary/VascularJob... ...Coronary/VascularThe Director, Clinical Affairs of... ...cross-functionally with Medical Affairs, R&D, Regulatory... ...within the medical device industry, and 5+ years... ...medical device clinical trial practices, Good Clinical...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week- We're seeking a Director of Clinical Affairs to own end-to-end execution of regulatory... ...studies for a growing medical device company. This is a hands-on,... ...someone who has taken devices or SaMD from earliest-stage concept all the way through trial completion and into post-...Medical deviceContract work
- WHOOP in Boston, MA is seeking a Director, Clinical Operations to spearhead the studies supporting SaMD health features. You will own the operational strategy and study... .... This role requires deep expertise in clinical trial operations, vendor oversight, and regulated...
$180k - $200k
...errors, and optimize pregnant women’s medical path. Sonio's mission is to improve... ...About The Role You'll be the first Clinical hire in the US, leading a team covering... ...in Clinical Affairs at a medical-device company, ideally in AI / SaMD; healthtech scale-up experience Strong...Medical deviceRemote workWorldwideFlexible hours- ...Executive Director, Clinical Platforms & Product Development About the Company Well-established... ...Categories Health Care Clinical Trials Construction Facilities... ...clinical research clinical trials and medical device trials About the Role The...Medical deviceContract work
$160.6k - $240.8k
...DescriptionGeneral Summary:The Clinical Study Quality Lead (SQL), Associate Director is responsible for... ...oversight of clinical trial operations and applicable... ...clinical trials, understand medical terminology, standards... ...experience with medical device manufacture and...Medical deviceFull timeWork experience placementSummer workWork at officeRemote workFlexible hours2 days per week$217.5k - $389.4k
...to address significant unmet medical need and bring transformative... ...space rarely wait. Phases of clinical development can compress, blend... ...require the use of medical devices.Purpose:Lilly Regenerative Medicine... ...interpretation of clinical trial data.Through the application...Medical deviceLocal areaFlexible hours- ...Senior Manager, Clinical Trials Job Location: Irvine, USA | SanFrancisco, USA | Boston, USA... ...individual owns operational execution of device studies required for marketing claims... ...position works cross-functionally with Medical Affairs, Clinical Development, Regulatory...Medical deviceTemporary workLocal areaFlexible hours
$220k - $245k
...bodies and daily lives.As the Director of Health Economics &... ...strategy that translates WHOOP’s clinical performance into measurable... ...economics within digital health, medical devices, diagnostics, or healthcare... ...as a Medical Device (SaMD) programs or regulated product...Medical deviceFull timeWork at officeRemote workRelocation$133k - $212k
...DescriptionMedical Safety Manager, HPMThe Medical Safety Manager, Hospital... ...Introduction (NPI) projects, clinical studies, and Post-Marketing... ...safety studies and medical device vigilance activities to... ...Analyzes safety data from clinical trials and post-market surveillance...Medical deviceFull timeWork at officeImmediate startWork visaRelocation package3 days per week$116k - $182.27k
...supply plan for innovative medicines in clinical development. The Manager, Planning Lead... ...information, translating clinical trial protocol information into a study supply... ...in, or MBA is preferred.Experience with Medical Devices a plus.Basic understanding of GxP principles...Medical deviceMinimum wageContract workLocal area- ...leadership role will provide medical expertise and strategic... ...) therapies. As the clinical voice of the physician... ..., the Global Medical Director will partner with Clinical... ...oversight for clinical trials, including protocol... ...safety signal evaluation, device performance assessment...Medical device
- ...isn't it.The RoleWe're looking for a Director of Clinical Research who will own Eight Sleep's clinical... ...managementExperience with biosensing devices or consumer health technology pursuing... ...engagementsExperience supporting medical device regulatory studiesWhy Join Eight...Medical deviceFull timeImmediate startWorldwideSleeping nightsNight shift
- ...Responsible for supporting the clinical development Neuroscience team with medical and safety monitoring.... ...observation of clinical trials to ensure safety and... ...level Seniority level Director Employment type Employment... ...and Marketing - Medical Device Hudson, MA $210,000.00-$...Medical deviceContract workRemote work
- ...to address significant unmet medical need and bring transformative... ...space rarely wait. Phases of clinical development can compress, blend... ...require the use of medical devices. Purpose: Lilly Regenerative... ...and interpretation of clinical trial data. Through the...Medical deviceLocal area
$146.3k - $234.1k
...and innovation. As Associate Director, Clinical Pharmacology &... ...exploratory studies through Phase 2/3 trials Expertise in translational... ...not limited to: ~ Medical, Dental and Vision Insurance... ...development of new therapies, medical devices, and diagnostics. As...Medical deviceHourly payWorldwide- ...Regulatory Affairs Associate to shape regulatory strategy for SaMD, AI-enabled technologies, and wearable health solutions. You will... ...in our Boston, MA office, this role requires 8+ years in medical device regulation, strong communication skills, and the ability to translate...Medical deviceWork at office
$155k - $185k
...are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely... ...Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver...Medical deviceFull timeWork at officeRelocation$170k - $220k
...strategy for digital health and AI-enabled technologies. This role involves developing regulatory approaches for Software as a Medical Device (SaMD) and serving as a primary advisor to cross-functional teams on compliance and strategic guidance. The ideal candidate will...Medical device- ...-purpose regulatory frameworks across consumer, research, and SaMD products, including AI/ML-enabled solutions. You will partner... ...expansion. Role requires 5+ years in regulatory affairs within medical devices or digital health; proficiency with Jira, GitHub, and document...Medical device
$154.4k - $242.55k
...DescriptionOBJECTIVES/PURPOSE: • The Associate Director, GCSC Operations Lead is... ...Associate Director manages Clinical Supply project delivery in... ...Takeda Global R&D Clinical Trials and other supportive... ...preferred.Experience with Medical Devices a plus.Strong understanding...Medical deviceMinimum wageContract workTemporary workLocal areaRemote work$170k - $230k
...engineering and science teams that bring SaMD products from research through... ...partner deeply across regulatory, quality, clinical science, product, software, and firmware... ...required to operate inside a regulated medical device development environment (FDA, IEC 62304,...Medical deviceFull timeWork at officeRelocation$155k - $185k
WHOOP is seeking a Senior Program Manager, SaMD, located in Boston, MA. This role involves driving execution of Software as a Medical Device programs, collaborating with various teams to ensure regulatory compliance and successful product delivery. Candidates should have...Medical device- A leading biomedical solutions company located in the Boston area is seeking a qualified individual to develop test plans for clinical trials, ensuring compliance with regulations and standards. The successful candidate will have a degree in Biomedical Engineering and experience...Medical device
$145k - $195k
...bodies and daily lives.As a Senior Clinical Scientist, you will independently own... ...science, data analysis, epidemiology, medical device, digital health, SaMD, pharmaceutical, biotech, or real-... ...regulations, ICH-GCP, ISO 14155, clinical trial design, and evidence-generation...Medical deviceFull timeWork at officeRemote workRelocation
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