Senior Regulatory Affairs Lead, Medical Devices
G-MedTech
Siemens Healthineers is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions, maintain lifecycle documentation, and ensure regulatory compliance across product development. You will collaborate with cross-functional teams, prepare technical files, and train staff on country requirements to keep products market-ready. The role involves supporting audits and inspections and leading regulatory projects as needed. #J-18808-Ljbffr G-MedTech
- Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking a Senior Regulatory Affairs Specialist to lead regulatory activities across the product lifecycle and provide strategic guidance onsite in Massachusetts...SeniorMedical device
- 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 with...SeniorMedical deviceRemote job
$169.58k - $233.18k
...your unique contributions. As a Senior Director, Program Management, you will lead the execution of strategic... ...across R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, Supply Chain,... ...programs within a global, regulated medical device environment from program...SeniorMedical deviceTemporary workWork at officeLocal area- Senior Regulatory Affairs Specialist - Onsite Endofix Medical is a small, innovative medical device company developing advanced endoscopic surgical devices. We are seeking an experienced... ...Senior Regulatory Affairs Specialist to lead regulatory activities and provide...SeniorMedical deviceContract work
$109.25k - $149.5k
...standards of care.SUMMARYThe Lead Auditor, Quality... ...portfolio of leading medical devices. Ensure that the corporate... ...with auditees and senior management while helping... ...procedures and the regulatory and legislator requirements... ...Chain, Regulatory Affairs, Product Development,...Medical deviceFull timeTemporary workWork experience placement- Anagram Therapeutics, Inc. is seeking an Associate Director of Regulatory Affairs CMC to lead regulatory CMC activities across our portfolio through all development stages in a fast-paced biotech environment. You will develop regulatory-CMC strategies, coordinate INDs/...Senior
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- Senior Medical Device Compliance Engineer at SharkNinja in Needham, MA leads design controls and post-market compliance across SharkNinja’s Medical Devices portfolio.... ...developed and maintained in compliance with global regulatory requirements within a fast-paced consumer...SeniorMedical deviceOverseas
- SharkNinja in Needham, MA is seeking a Senior Medical Device Compliance Engineer to own design controls and post-market sustaining activities... ...its Medical Devices portfolio. You will ensure global regulatory compliance, lead DHF reviews, risk management, and ECN processes,...SeniorMedical deviceOverseas
- SharkNinja is seeking a Senior Medical Device Compliance Engineer in Needham, MA to lead design controls and post‑market compliance across medical devices. This hands‑on role collaborates with Engineering, Legal, Program Management and Quality to ensure safe, compliant...SeniorMedical deviceOverseas
- Siemens Healthineers in the United States seeks a Senior Director, Program Management to lead large, complex Systems and Informatics product development... ...leadership across R&D, Marketing, Quality, Regulatory Affairs, Manufacturing, Supply Chain, Service, and Operations...SeniorMedical device
$92.2k - $141.4k
...yet, you’ll fit right in.The Senior Product Safety & Compliance... ...partners for all aspects of regulatory compliance and product certification... ...will be responsible for leading multiple certification... ...includes active participation in medical device regulatory pathways...SeniorMedical deviceTemporary workLocal areaFlexible hoursShift work$87.8k - $150k
...been invented yet, you’ll fit right in. Senior Medical Device Compliance Engineer Needham, MA,... ...and sustained in compliance with global regulatory requirements—while operating within a... ...audit-ready technical documentation. Lead and support the creation, review, and...SeniorMedical deviceContract workTemporary workLocal areaOverseasFlexible hours- ...individual to join our growing team as Senior Business Development Manager. This role... .... Experience working with large pharma, medical device, IT or DOD is preferred. Proven track record... ..., email outreach, social selling, lead generation, networking, and relationship...SeniorMedical deviceBase plus commissionContract workWork at officeLocal areaRemote work
- ...manufacturing engineering for sutures and related devices. The role emphasizes design controls, regulatory compliance, and cross‑functional... ...requirements. The position requires a BS in engineering, 4+ years in medical devices, and experience leading projects. #J-18808-Ljbffr...SeniorMedical device
$125.35k - $172.5k
...standards of care.Oracle Supply Chain Planning Lead / SME with 12+ years of experience... ..., and enhancements for large-scale Medical Device company, ensuring compliance with industry... ...ensuring GxP, FDA, and other regulatory compliance in Life Sciences supply chain...SeniorMedical deviceFull timeTemporary workWork at officeRemote workMonday to Friday- PPG is seeking a Trade Compliance Manager in Avon, MA, for their Aerospace Business. This hybrid role involves interpreting export control regulations, providing guidance, and ensuring compliance with applicable laws. The ideal candidate will have 5+ years of experience...Senior
- Mott MacDonald is seeking a Senior Quality Manager to lead quality initiatives across major North American infrastructure programs. You will direct PQMPs, audits, and continuous improvement, ensuring compliance with client requirements and corporate standards. The role...SeniorFor contractors
- ...strategies across a diverse mRNA portfolio from development through commercial. You will lead cross-functional teams, oversee stability protocols, and author stability sections for regulatory submissions, ensuring regulatory readiness and uninterrupted patient supply. This...Senior
- ...governance, risk management, and practical control strategies in a fast‑paced biopharma environment. You will partner with cross‑functional teams to drive EHS readiness, culture, and compliance, with a focus on complex regulatory requirements, #J-18808-Ljbffr ModernaSenior
- ...enhance operational readiness with a primary responsibility to lead EHS events and ensure compliance with EHS programs. Ideal candidates... ...at least 7-10 years of EHS experience, demonstrating strong regulatory knowledge and leadership in biopharmaceutical settings....Senior
- Home Market Foods, a leading frozen foods manufacturer, seeks an Associate Director of Quality Assurance & Food Safety to lead daily... ...environment. You will collaborate with Operations, R&D, Sanitation and Regulatory teams to ensure compliance and drive continuous improvement....Senior
$120k - $130k
...Senior Software QA Engineer The Senior Software QA Engineer... ...their experience in modern medical device development, this individual will work closely with our Regulatory Affairs / Quality Assurance and Engineering... ...will actively propose and lead process improvements to...SeniorMedical deviceHourly payWork at officeFlexible hours- ...manage EHS events, investigations, CAPA, and program ownership across R&D, facilities, and manufacturing enabling functions. You will lead high‑risk programs, drive MOC, audits, compliance improvements, and leverage data analytics and AI-enabled tools to strengthen EHS...SeniorLocal area
- Siemens Healthineers AG is looking for a Regulatory Affairs Professional to join their team in Walpole, MA. This hybrid position entails... ...discipline and at least 2 years of experience in IVDs or medical devices. Strong knowledge of US/EU regulations and good attention...Medical device
- Replimune seeks a Quality Systems specialist to administer and optimize eQMS platforms, ensuring regulatory compliance and inspection readiness. The role supports governance, workflows, and cross-functional collaboration across sites. The ideal candidate has deep GxP experience...Senior
- ...years of web development experience and a strong track record in architecting high-volume web applications. Responsibilities include leading development teams, establishing performance guidelines, and collaborating with various stakeholders to ensure successful solution...Senior
- Bond Building Construction Inc. seeks a senior Estimator/Preconstruction lead to manage bid budgets, coordinate with estimating and project teams, and drive value‑management pricing for both trades and subs. The role requires a BS in a related field and 15+ years of local...SeniorLocal area
$90k - $130k
A leading surveying firm in Norwood seeks a Senior/Principal Land Surveyor licensed in Massachusetts. The role requires a minimum of 5 years of experience... ...Management team. Benefits include paid holidays, PTO, medical insurance, and 401k matching, with a competitive salary...Senior$110k - $130k
...clinical markets. Job Summary: The Senior Quality Engineer will be responsible... ...production, and data monitoring. This role leads quality initiatives and projects,... ...the technical sciences ~7 plus years Medical Device/IVD Experience as a Quality Engineer, or...SeniorMedical deviceHourly payWork at officeFlexible hours
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