Regulatory Affairs Manager
4 weeks ago
Regulatory Affairs Managerš 4 days on-site | Bedford, MA š¼ Medical Device Company Commercial StageWere seeking a Regulatory Affairs Manager to support U.S. and international regulatory activities as the company moves through commercialization and prepares for global expansion.This position will collaborate closely with Quality, R&D, and senior leadership to manage regulatory submissions and documentation for Class II and Class III medical devices.Key ResponsibilitiesPrepare, submit, and maintain FDA 510(k), IDE, and PMA applications.Develop and update EU MDR (2017/745) technical documentation.Support MDSAP readiness and registration activities across multiple markets (Health Canada, TGA, ANVISA, PMDA).Ensure compliance during design control, change control, and risk management processes.Serve as a regulatory liaison with FDA and Notified Bodies.Contribute to ISO 13485 system improvements and post-market compliance activities.QualificationsExperience preparing and managing medical device submissions (Class II or III).Strong understanding of FDA, EU MDR, and MDSAP requirements.Familiarity with ISO 13485 and design control documentation.Detail-oriented and organized, with the ability to manage multiple priorities in a collaborative environment.This role offers the opportunity to contribute directly to the companys regulatory strategy and gain visibility across all functions.
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Lexington Medical, Inc Full timeSenior Regulatory Affairs Specialist ā Lexington Medical, IncJoin to apply for the Senior Regulatory Affairs Specialist role at Lexington Medical, Inc.Company OverviewLexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design...
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Senior Regulatory Affairs Specialist
3 weeks ago
Bedford, United States Lexington Medical Full timeLexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving $6B+ surgical...
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Vice President Regulatory Affairs
2 weeks ago
Bedford, United States Pragmatic Full time1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from PragmaticPractical Recruitment. Life Changing ResultsVP or Head of Regulatory & QualityLocation: Bedford, MA (Hybrid, 4 days on site, 1 day remote)Industry: Medical DeviceEmployment Type: Full-time | Competitive...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Senior Regulatory Affairs Specialist
7 days ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Director, Regulatory Affairs
3 weeks ago
Bedford, United States Lantheus Brand Full timeDirector, Regulatory Affairs - StrategyLantheus is headquartered in Bedford, Massachusetts with offices in Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio.Lantheus is an entrepreneurial, agile, growing...
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Director, Regulatory Affairs
3 weeks ago
Bedford, United States Lantheus Full timeDescriptionLantheus (NASDAQ: LNTH) is the leading radiopharmaceutical-focused company, delivering life-changing science to enable clinicians to Find, Fight and Follow disease to deliver better patient outcomes. Headquartered in Massachusetts with offices in New Jersey, Canada, Germany, Sweden, Switzerland and United Kingdom, Lantheus has been providing...
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Regulatory Affairs Specialist II
5 days ago
Bedford, Massachusetts, United States Werfen Full time $85,000 - $105,000 per yearOverview:Position Summary:Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device...
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Manager, Regulatory Project Management
2 weeks ago
Bedford, United States Stoke Therapeutics Full timeManager, Regulatory Project Management Stoke Therapeutics Join to apply for the Manager, Regulatory Project Management role at Stoke Therapeutics. About Stoke: Stoke Therapeutics (Nasdaq: STOK) is a biotechnology company dedicated to restoring protein expression by harnessing the bodys potential with RNA medicine. Using Stokes proprietary approach, the...
