Senior Regulatory Affairs Specialist: SaMD & MedTech
OrganOx
OrganOx is seeking a Senior Regulatory Affairs Specialist to prepare regulatory submissions (FDA Q-Submissions, INDs, IDEs and PMAs) for North America, and to assist in implementing the company’s quality goals and objectives. The role reports to the Director, Regulatory Affairs, Software and Innovation, and collaborates with cross-functional teams. It may require up to 5% travel domestically or internationally, with a flexible remote or hybrid on-site work arrangement. #J-18808-Ljbffr OrganOx
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs Specialist for Ultrasound collaborates with regulatory... ...experience required. Experience with SaMD or SiMD submissions is strongly...SeniorFull timeWork at officeImmediate startWork visaRelocation package3 days per week- ...countries and regions. Position Summary The position of Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions (e.g.... ...compliance. Experience with Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), Cybersecurity and...SeniorFor subcontractorRemote workFlexible hours
- ...Foundation Medicine in Boston seeks a Senior Specialist, Regulatory Affairs (CDx) to lead regulatory submissions, shape strategy, and guide cross-functional teams through FDA pathways for companion diagnostics. You will prepare packages, respond to agency inquiries, review...Senior
$80k - $200k
...experienced consultant to lead MedTech Regulatory Information Management (RIM)... ...our customers’ Regulatory Affairs and Operations processes... ...Software as a Medical Device (SaMD) or combination products Experience... ...with our group's Senior Leader. Once all interviews...SeniorWork at officeLocal areaWork from homeFlexible hours- ...Elucid, a Boston-based medical technology company, seeks a Senior Director of Product to own the strategy, roadmap, and execution of our SaMD portfolio. You will lead a team of Product Managers and partner with Engineering, Marketing, Sales, and Clinical to deliver market...Senior
$80k - $200k
...experienced consultant to lead MedTech Regulatory Information Management (RIM)... ...our customers’ Regulatory Affairs and Operations processes... ...Software as a Medical Device (SaMD) or combination products Experience... ...with our group's Senior Leader. Once all interviews...SeniorWork at officeLocal areaWork from homeFlexible hours$120k - $200k
A leading SaaS company in Boston seeks a Senior Product Manager for MedTech to drive strategy and functionality within its product ecosystem. The role requires a minimum of 5 years in MedTech operations or product management, expertise in software product management, and...Senior$155k - $185k
...understanding of their bodies and daily lives.We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of... ...the full product lifecycle, from development through regulatory submission and launchPartner with Machine Learning,...SeniorFull timeWork at officeRelocation$170k - $230k
...engineering and science teams that bring SaMD products from research through validation... ...submission, and production deployment.As a Senior Manager, SaMD, you will own delivery and... ...the function, and partner deeply across regulatory, quality, clinical science, product, software...SeniorFull 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...Senior- ...and support reporting recommendations when appropriate Document review outcomes clearly and concisely Ensure work aligns with internal policies, procedures, and regulatory requirements Analyze trends, findings, and data to support quality and risk management initiativesSenior
$163k - $204k
...affiliated insurance companies, through internal and external managers. The Investments Compliance team provides compliance and regulatory support to AIG’s Investments group, along with assisting in the oversight of external managers. The ideal candidate will have extensive...SeniorFull timeWork at office$150k - $200k
...exchange-traded funds (ETFs), ensuring adherence to applicable regulatory requirements and internal policies. This role will work closely... ...and level of relevant experience, plus discretionary bonus.#MID_SENIOR_LEVELAt Franklin Templeton, we believe your benefits should...SeniorFull timeLocal area3 days per week$124k - $280k
...Life SciencesSpecialismOperationsManagement LevelSenior ManagerJob Description & SummaryThe OpportunityAs a Pharma & MedTech End-to-End Supply Chain Senior Manager, you will play a pivotal role in optimizing supply chain operations and enhancing end-to-end visibility and...SeniorFull timeH1b- Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutions, MTG has the knowledge and experience to ensure compliance with pharmaceutical...Senior
- ...Senior Compliance Specialist Needed for Inusurance Company in Downtown Boston, MA The Legal Department of an insurance company is seeking an... ...business unit's compliance liaisons and provide guidance on regulatory requirements, root cause analysis and corrective action...Senior
$80k - $200k
...Senior Consultant – MedTech Clinical OperationsVeeva Systems is a mission-driven organization and pioneer in industry cloud, helping life sciences companies bring therapies to patients faster. As one of the fastest-growing SaaS companies in history, we surpassed $3B in...SeniorWork at officeLocal areaRemote workWork from home- ...Are:Accenture’s Life Sciences MedTech practice sits at the... ...execution, we help clients navigate regulatory complexity, accelerate product... ...You build relationships with senior R&D and commercial leaders at... ...product development, regulatory affairs, clinical operations, and...SeniorFull timeLive inWork at officeLocal areaNight shift
$106k - $130k
...Join to apply for the Regulatory Affairs Senior Associate role at PepGen . The Regulatory Senior Associate will support key aspects of regulatory activities to aid the development of PepGen’s novel peptide‑oligonucleotide conjugate therapeutics targeting neuromuscular...SeniorFull timeWork at office- Motional is seeking a Benefits Analyst in Boston to support Health & Welfare, Leave, Recognition, and 401(k) programs. You will be the SME for Benefits & Leave and lead compliance tasks including audits, required filings, testing, and reporting, while ensuring timely funding...Senior
$120k - $160k
...understanding of their bodies and daily lives.WHOOP is looking for a Regulatory Affairs Specialist II, Expansion to be a core member of the Digital Health... ...access activities for Software as a Medical Device (SaMD), wearable technologies, and digital health products. This...Full timeWork at officeRelocation- State Street is seeking a Financial and Regulatory Reporting, NPORT Operations Senior Associate to manage monthly N-PORT and annual N-CEN filings for clients, located in Boston, MA or Kansas City, MO. You will collaborate with clients and internal teams to resolve issues...Senior
- ...perform critical primary trade reviews, including annuity purchases. The role involves coordinating account reviews, supporting regulatory exams, maintaining supervisory procedures, and delivering dashboard reporting to monitor department activities and drive process...Senior
- Siemens Healthineers in the United States is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and lifecycle documentation for medical devices and IVDs. You will serve as a regulatory expert, guide design control activities, and collaborate...SeniorRemote job
- ...Iterative Health is headquartered in Cambridge, Massachusetts, and New York City with 250+ employees world-wide.As a Senior Clinical Regulatory Specialist at Iterative Health, you will play a key role in supporting the compliant execution of Phase 2-4 industry-sponsored...SeniorTemporary workWork at office2 days per week
$106k - $130k
A biotech company is seeking a Regulatory Affairs Senior Associate in Boston. The role focuses on supporting regulatory activities for innovative therapeutics in neuromuscular conditions. Candidates should have a bachelor's degree in a scientific discipline, 2+ years in...Senior$90k - $200k
...Senior Manager, Financial Investigations Kroll's North American Investigations, Diligence and Compliance practice is seeking a Senior... ...a broad range of complex investigations, forensic accounting, regulatory compliance, including business intelligence, internal (client)...SeniorTemporary workFlexible hours$147.4k
Posting Description SENIOR LICENSING AND BUSINESS DEVELOPMENT OFFICER, Technology Licensing Office, is responsible for the commercialization of MIT’s IP portfolio arising from research and activities on MIT’s campus; managing a large portfolio of cases, including, technology...SeniorFull timeWork at officeVisa sponsorship$119k - $218.3k
Position Summary Senior Consultant - Risk, Regulatory, & Licensing - Digital Assets Regulatory & Financial Risk Ready for a fast-paced, impactful... ...or certification(s) in risk, compliance, regulatory affairs, or a related field (e.g., CRCM, CAMS, CISA, JD, or LLM)...SeniorWork at office- Senior Regulatory Affairs Specialist - Onsite Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking an experienced and highly motivated Senior Regulatory Affairs Specialist to lead regulatory activities...SeniorContract work
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