Senior Global Regulatory Affairs Leader (Medical Devices)
Werfen
Werfen in Bedford, MA seeks a Regulatory Affairs professional to lead pre-market activities for FDA, Health Canada and EU submissions, ensuring labeling and registrations meet global requirements. You will collaborate with R&D and Marketing to prepare FDA 510(k), HC licenses, and EU Notified Body submissions, guiding projects through regulatory pathways for successful launches. Candidates bring at least 8 years of medical device regulation experience with strong written and verbal communication #J-18808-Ljbffr Werfen
- Belmont Medical Technologies is seeking a Sr. Customer Support Representative to support the Head of Customer Service and serve major global customers. You will handle complex inquiries, coordinate with cross-functional teams, and drive process improvements to enhance...SeniorMedical deviceFull timeLocal area
- Quanterix is seeking an experienced Senior Manager, Tax to lead global tax operations from Billerica, MA in a hybrid environment. This role partners with Accounting, SEC Reporting, Treasury, Legal, and external advisors to drive compliant, scalable tax processes and clear...Senior
- Werfen seeks a Senior Product Manager, Upstream Hemostasis Reagents, to drive global portfolio strategies across the hemostasis... ..., coordinating with R&D, Regulatory, Quality, Operations, and Marketing... ...experience in IVD or medical devices, a track record of revenue growth...SeniorMedical device
- Anika Therapeutics, Inc. seeks a Regulatory Affairs Project Manager/Sr. Manager to lead cross-functional... ...programs for pharma, biotech, and medical device products. You will own regulatory... ...readiness, and program coordination across global teams. The role requires NDA...SeniorMedical device
- Real is seeking a Sr. Global Product Manager in Billerica, MA to lead global product strategy within the medical devices sector and drive innovative solutions that improve healthcare outcomes. This permanent role offers ownership of end-to-end product lifecycle and collaboration...Medical devicePermanent employment
$137k - $215.27k
...supply."ACCOUNTABILITIES:The Senior Manager, Planning Lead will... ...plan, document, and facilitate global cross-border supply... ...country investigational product regulatory requirements for delivery of... ...is preferred.Experience with Medical Devices a plus.Ability to influence...SeniorMedical deviceMinimum wageContract workLocal area- ...Corporation is seeking a Sr. Supplier Quality Engineer II to join the Global Quality team in Burlington, MA. The role focuses on ensuring... ...across development, manufacturing, and distribution of medical devices and pharmaceuticals. You will lead audits, drive corrective...SeniorMedical device
- Excelitas Technologies Corp. in Billerica, MA, seeks a Senior Supply Chain Manager to lead the end-to-end supply chain, including procurement... ...while driving cost reductions and KPI performance across global suppliers and internal teams. The role requires 5-10+ years in materials...Senior
- Werfen seeks a Senior Leader to drive software testing, qualification, and test automation strategy in Bedford, MA. You will lead a technical... ..., shaping frameworks and CI processes to ensure quality in medical device software. You will partner with software leadership to...SeniorMedical device
$140k - $185k
...requires a bachelor's degree in engineering, 9+ years in medical devices, a strong understanding of regulatory standards, and proficiency in quality management... ...other engineers. Competitive salary range of $140,000 to $185,000 per year. #J-18808-Ljbffr Insight GlobalSeniorMedical device- Spryte Medical seeks a Director of Regulatory Affairs to guide global regulatory strategy for a portfolio of neurovascular imaging devices. You will lead cross‑functional teams, manage complex submissions, and oversee external regulators to accelerate market access. The...Medical device
- Senior Director, Global Regulatory Lead, GI & Inflammation About the role: The Global Regulatory Leads, Senior Director is responsible for ensuring... ..., enhancing their skills and knowledge in regulatory affairs Strong strategic planner with a proven ability to anticipate...SeniorFull timeLocal area
- ...impact?As a key member of the Global Quality team, you will help... ...distribution of innovative medical devices and pharmaceutical products.... ...inspections to ensure compliance with regulatory and company requirements.... ..., R&D, Regulatory Affairs, and Quality teams to support...SeniorMedical deviceLocal area
$227k - $362k
...TitleGlobal Marketing Leader, Claims, Value & PricingJob... ...is hiring a Global Marketing Leader to build... ...stronger conversations with senior stakeholders.• Lead... ...work in a global medical device or healthcare technology... ...working with clinical, regulatory, legal, quality and commercial...Medical devicePrice workFull timeWork experience placementWork at officeImmediate start3 days per week- ...Responsible for preparation of regulatory submissions (domestic... ...pharmaceutical and medical technology company... ...symbol “GKOS”. Our global headquarters is in Aliso... ...establishment registration and device listing submissions... ...basic Regulatory Affairs functions, such as...SeniorMedical deviceLocal area
- Anika is seeking an experienced Regulatory Affairs Project Manager/Sr. Manager in the United States to lead cross-functional regulatory programs across pharma, biotech, and medical device products. The role focuses on regulatory planning, submission readiness, and program...SeniorMedical device
- Cynosure Inc. is seeking a regulatory professional to lead complex submissions and guide product development through regulatory... ...markets. Required are 5-8 years in regulatory affairs for medical devices, strong knowledge of FDA/IVD regulations, and a proven ability...Medical device
$170k - $190k
...that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose... ...and respiratory conditions.Job TypeHybridJob SummaryThe Senior Manager, Global Tax will be primarily responsible for the preparation and...SeniorMedical deviceMinimum wageOngoing contractFull timeFixed term contractLocal areaRemote workWorldwide$220k - $270k
...meaningful difference in people's lives. Our medical devices, software and related services are used... ...public safety, and military customers globally. Products include AEDs, trauma kits,... ...of ZOLL!Job TypeHybridJob SummaryThe Senior Director, Global Commercial Contracts oversees...SeniorMedical deviceMinimum wageOngoing contractFull timeContract workLocal areaRemote workWorldwide- Sr. Global Product Manager Opportunity in Billerica, United States About the Role Are you ready to take your career to the next level? Our client, a leader in the Medical Devices & Equipment sector, is seeking a driven and strategic Sr. Global Product Manager to join their...SeniorMedical devicePermanent employment
- What You’ll DoThe Regulatory Affairs Project Manager/Sr. Manager leads and coordinates cross-functional... ...pharmaceutical, biotechnology, and medical device products. In this role, you serve as... ...deliverables and alignment with global regulatory and business objectives. This...SeniorMedical deviceFull timeImmediate start
- Vericel Corporation in Burlington, MA is seeking a Senior Manager, Regulatory Affairs to oversee regulatory submissions and strategy across biologics... ...guide regulatory strategy, and ensure alignment with FDA and global requirements, shaping a growing portfolio in cell...Senior
$127.9k - $191.8k
...the organization.Your Role:The Global Labeling Excellence Lead is... ...global labeling activities within Regulatory Quality Safety (RQS). This... ...product labeling, regulatory affairs, regulatory operations,... ...regulatory, safety, quality, medical, commercial, and regional stakeholders...SeniorLocal areaImmediate start- UCB is seeking a Senior Real-World Evidence Expert to independently design, lead, and deliver global evidence studies. The role targets informing regulatory and payer interactions and advancing disease-area understanding, with collaboration across US and non-US teams in...Senior
- ...with physicians and scientists worldwide. This hybrid role emphasizes patient-centric trial design and seamless execution across a global network. You will manage study design, protocols, data reviews, and cross-functional coordination, with 6+ years in clinical trials...SeniorWorldwide
- Korro seeks a senior clinical operations leader to drive early phase global trials in rare diseases. You will oversee CROs, study design, budgets, and timelines... ...requires 8+ years in clinical development, strong regulatory knowledge, and a track record delivering FIH...Senior
- Werfen is seeking a Senior Systems Engineer to lead system-level verification and validation... ...while supporting risk management and regulatory compliance. Qualification includes a... ...product development and experience in medical device environments. #J-18808-Ljbffr...SeniorMedical device
- ...Pharmaceuticals in the United States is seeking a Mechanical and Electromechanical Engineer to provide sustaining engineering for existing medical products and contribute to new projects. You will support product investigations, develop design control documents, perform tests,...SeniorMedical device
- Pulpdent Corporation is seeking a Head of Regulatory Affairs to lead global regulatory strategy across the full product lifecycle. You will ensure compliance with domestic and international requirements and partner with R&D, manufacturing, and marketing to drive growth...Medical device
- Pulpdent Corporation in Watertown, MA, seeks a Head of Regulatory Affairs to guide global regulatory strategy across R&D, manufacturing, and... ...products worldwide. The ideal candidate has 10+ years in medical devices regulatory affairs, a strong leadership track record,...Medical deviceWorldwide
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Global Regulatory Affairs Leader (Medical Devices). Be the first to apply!
- key team leader Bedford, MA
- team leader mental health Bedford, MA
- office team lead Bedford, MA
- team leader Bedford, MA
- recruitment team leader Bedford, MA
- helpdesk team lead Bedford, MA
- compliance team leader Bedford, MA
- team lead Bedford, MA
- clinical team leader Bedford, MA
- quality control team lead Bedford, MA

