Sr. Medical Affairs Specialist AtriumSr. Medical Affairs SpecialistBoston, MA$75–$85 / hourMedical Affairs Specialist will play a key role in interpreting clinical evidence, responding to complex medical inquiries, and supporting evidence generation strategies that inform product development and healthcare decision-making. Medical Affairs Specialist will leverage clinical expertise and scientific knowledge to support medical communications, evidence dissemination, and cross-functional initiatives that communicate the clinical value of innovative medical technologies.
Regulatory Affairs Specialist II, Expansion WhoopRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
Senior International Regulatory Affairs Specialist Butterfly Network IncSenior International Regulatory Affairs SpecialistBurlington, MAThis role requires a strong ability to translate evolving regulatory requirements-such as EU MDR 2017/745-into clear, actionable plans, while partnering cross-functionally to align regulatory expectations with fast-paced product and software development cycles. In addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond.
Senior International Regulatory Affairs Specialist Butterfly NetworkSenior International Regulatory Affairs SpecialistBurlington, MAIn addition to its medical imaging products, Butterfly Embedded is the Company's Ultrasound-on-Chip licensing and co-development program designed to enable a new wave of ultrasound-enabled technologies across non-competitive healthcare markets and beyond. Utilize and maintain regulatory systems and tools (e.g., document management systems, regulatory submission platforms, and tracking tools) to support ongoing regulatory activities, submissions, and communications with regulatory bodies.
Senior Regulatory Affairs Specialist PhilipsSenior Regulatory Affairs SpecialistCambridge, MA$99,000–$157,000 / yearThe actual base pay offered may vary within the posted ranges depending on multiple factors including job-related knowledge/skills, experience, business needs, geographical location, and internal equity. Lead global regulatory intelligence initiatives, contribute to regulatory and product registration strategies, and help implement global regulatory roadmaps based on the competitive landscape and marketing objectives.
NewRegulatory Affairs Specialist II, Expansion Whoop IncRegulatory Affairs Specialist II, ExpansionBoston, MA$120,000–$160,000 / yearThis role focuses primarily on international regulatory submissions, EU MDR Technical Documentation, global market registrations, and lifecycle regulatory support while partnering cross-functionally to help bring innovative health technologies to markets around the world. At WHOOP, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of WHOOP and share in the company's long-term growth and success.
Regulatory Affairs Specialist CareerscapeRegulatory Affairs SpecialistBoston, MA$90,000–$125,000 / yearFull timeOur client, a clinical-stage biotechnology company based in Boston's Seaport District, is looking for a Regulatory Affairs Specialist to join their growing regulatory team. The position reports directly to the VP of Regulatory Affairs and works closely with cross-functional teams including R&D, clinical operations, and quality assurance.
Contract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876) Corning IncContract Specialist, Regulatory Affairs (Tewksbury, MA, US, 01876)Tewksbury, MA$71,252–$97,972 / yearOur health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. Today, we accelerate and transform life sciences, mobile consumer electronics, optical communications, display, automotive, and solar markets.
NewSr. Regulatory Affairs Specialist Glaukos CorpSr. Regulatory Affairs SpecialistBurlington, MAOur constant pursuit of game-changing technologies that disrupt legacy treatment paradigms is encapsulated in the Glaukos mantra "We'll Go First," which articulates our willingness to take chances, our determination to forge new ground, and our commitment to continuous improvement in all that we do. Founded in 1998, Glaukos Corporation is an ophthalmic pharmaceutical and medical technology company focused on developing and commercializing novel therapies for the treatment of glaucoma, corneal disorders, and retinal diseases.
Senior Regulatory Affairs Specialist Boston Scientific CorpSenior Regulatory Affairs SpecialistMarlborough, MAAt Boston Scientific, our Urology business provides proven, leading solutions to treat several common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), overactive bladder, urinary and fecal incontinence, and pelvic floor disorders. Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy, regulatory pathway development, testing requirements, clarification and follow-up of submissions under review.
Sr. Specialist, Regulatory Affairs LeMaitreSr. Specialist, Regulatory AffairsBurlington, Massachusetts$110,000–$150,000 / yearFull timeProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. Candidate will prepare regulatory submissions for new products/product changes to ensure timely approval for market release and will follow up with regulatory agencies on these submissions.
Regulatory Affairs Specialist Integrated Resources, IncRegulatory Affairs SpecialistMansfield, MassachusettsContractorRegulatory Affairs SpecialistJob title: Regulatory Affairs SpecialistLocation: Mansfield, MA Duration: 5+ months (possibility of extension)Roles and Responsibilities:· The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity with FDA regulations for medical devices, submission experience of 510(k)s, generation of files necessary for outside U.S. notification and registration of medical devices, pre-clinical and/or clinical research, familiarity with ISO 14971, U.S. regulation 21 CFR 820, EC Directives 93/42/EEC as amended by Directive 2007/47/EC, EN ISO 13485, an understanding of basic safety requirements for medical devices, knowledge of current trends within U.S. and European medical device regulations, and intimate knowledge of regulations regarding reprocessing of medical devices in the U.S.· Provide regulatory assessments of manufacturing, design, material, and labeling changes.· The major deliverables are generally regulatory assessments, US letter to file (RAD), global regulatory strategy plans (GRSP), collaboration with RA International team to determine impact, and collaboration with the project team to review DHF documentation including but not limited to test protocols and reports.·
Senior Regulatory Affairs Specialist Siemens HealthineersSenior Regulatory Affairs SpecialistWalpole, MARemoteFull timeIt is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.". As a Senior Regulatory Affairs Specialist, you will be responsible to: Prepare, submit, and maintain regulatory submissions and lifecycle documentation, including FDA 510(k) submissions and notes to file, IVDR Class C recertifications, significant change notifications, and other regulatory applications as required.
Sr. Specialist, Regulatory Affairs LeMaitre Vascular IncSr. Specialist, Regulatory AffairsBurlington, MA$110,000–$150,000 / yearProvide support to currently marketed products including: reviewing of engineering change orders, labeling, promotional material, product changes and documentation for changes requiring regulatory approval. The Regulatory Affairs Manager will report to the VP of Regulatory Affairs and have the following primary responsibilities: Responsible for preparation of regulatory submissions, including FDA 510(K), CE Technical Documentations, Canadian Device Applications, etc.
NewGlobal Quality Mgt. Systems Engr # 26-18784 US Tech Solutions, Inc.Global Quality Mgt. Systems Engr # 26-18784Marlborough, MAPartnering closely with the Global Process Steward(s) for Supplier Controls and Sourced Device & Material Controls, this role will support the evaluation and prioritization of strategic initiatives, translate business and regulatory requirements into process enhancements, and lead implementation to ensure consistent, sustainable execution of Supplier Controls and Sourced Device & Material Controls that support emerging digital technologies and evolving global regulatory expectations. Assess and enhance supplier assessment and supplied device/material qualification processes, supplier lifecycle management, supplier change management, supplier remediation, supplier risk management, and the Supplier Change Impact Assessment (SCIA) process, ensuring supplier controls appropriately address software, cybersecurity, AI-enabled technologies, cloud services, digital health, and evolving regulatory expectations.
NewAssociate Director, Clinical Assay Strategy, Flu CSL SeqirusAssociate Director, Clinical Assay Strategy, FluWaltham, MA$179,000–$212,000This role is intended for a recognized subject matter expert who understands the scientific, operational, and regulatory evolution of influenza immunogenicity assessment, including HAI, microneutralization (MN), ELLA, and multiplex platforms, and can strategically navigate assay modernization while maintaining regulatory alignment. Headquartered in Melbourne, Australia, with major manufacturing hubs in Holly Springs, NC, and Liverpool, UK, the company operates the world’s largest cell-based vaccine facility and serves as a primary partner to governments for global pandemic preparedness.
NewPrin Regulatory Affairs Spec - Core Surgical innovations Medtronic PlcPrin Regulatory Affairs Spec - Core Surgical innovationsBoston, MAResponsibilities include participating on product development teams, developing global regulatory strategies, preparing US and international regulatory submissions, supporting pre and post market regulatory compliance activities and evaluating proposed product changes for regulatory impact and preparing necessary documentation. If you are applying to perform work for Medtronic, Inc. ("Medtronic") in any position which will involve performing at least two (2) hours of work on average each week within the unincorporated areas of Los Angeles County, you can find here a list of all material job duties of the specific job position which Medtronic reasonably believes that criminal history may have a direct, adverse and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.
Sr. Regulatory Affairs Spclst RadNet IncSr. Regulatory Affairs SpclstSomerville, MAQualifications include: • Bachelor's degree in relevant field (or equivalent experience) • 8 - 12 years working in a regulated industry (FDA and Software as a Medical Device preferred) • Strong knowledge of FDA Quality System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. Regulatory Affairs Specialist, this position will: • Represent Regulatory Affairs on cross-functional project teams and provide strategic input and technical guidance on product lifecycle planning and regulatory requirements for non-medical devices, and medical devices.
Associate Regulatory Affairs Director AstraZeneca PlcAssociate Regulatory Affairs DirectorCambridge, MA$135,624.80–$203,437.20 / yearAs a key member of the global regulatory strategy team (GRST), you are responsible for partnering with senior regulatory experts to support the end-to-end regulatory strategy planning, coordination, and execution of assigned cell therapy projects. The ARAD provides regulatory expertise and guidance on the clinical development requirements, including procedural and documentation requirements to regulatory and cross-functional teams, working flexibly within and across regions to achieve business objectives.
Sr Regulatory Affairs Spec Medtronic PlcSr Regulatory Affairs SpecBoston, MAThis role will partner closely with Geography Regulatory Affairs to support international submissions, government queries, registration documentation, product approval and clearance activities, product demand and release planning, and post-market regulatory compliance to help ensure continued product availability worldwide. The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).