- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Wolters Kluwer (Waltham, MA)
- …the applied interpretation of worldwide regulatory standards and laws applicable to the medical device industry eg, ISO, QSR, GMP. Must have EU MDR and FDA ... on-market medical devices including Software as a Medical Device (SaMD) within the Health Division...subject matter expert. + Assure integration and support of device regulations and compliance with company policies… more
- Sanofi Group (Cambridge, MA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... mindset and drives a culture of continuous improvement in compliance with Sanofi's behavioral and ethical standards. This critical...regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory… more
- Takeda Pharmaceuticals (Lexington, MA)
- …degree with 15+ years of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience + Experience with both ... deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device Clinical Strategy & Risk… more
- Eliassen Group (Marlborough, MA)
- …subsystems and systems. . Create design documentation to support medical device product development in alignment with regulatory requirements and industry ... **Mechanical Engineer- R&D, Medical Device ** **Marlborough, MA** **Type:** Contract.... Collaborate with cross-functional teams, including R&D, clinical, and regulatory , to review documentation and specifications to ensure alignment… more
- Integra LifeSciences (Boston, MA)
- …required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance , or other cGMP regulated product ... US Food and Drug Administration regulations, ISO 13485, and other applicable regulatory agencies as they pertain to laboratory testing. + Responsible for performing… more
- Medtronic (Newton, MA)
- …software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software (eg, HIPAA, ... that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a...The Affera Mapping and Ablation System is an innovative medical technology designed to treat patients with cardiac arrhythmias.… more
- Olympus Corporation of the Americas (Westborough, MA)
- …management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device industry is mandatory. Minimum of 10 years with BS/BA, ... materials. + Responsible for development, coordination, preparation and maintenance of US medical device submissions such as Pre-Submissions, 510(k)s, PMAs, IDEs… more
- Cardinal Health (Boston, MA)
- …functions and teams and delegate and direct non-legal tasks to support regulatory compliance implementation. **_Qualifications_** * Bachelor and JD degrees ... regulation) preferred * Experience in private practice strongly preferred * Familiarly with medical device and pharmaceutical regulation * Active license in good… more
- Tecomet (Woburn, MA)
- …medical device , aerospace, defense industries to achieve customer satisfaction, regulatory compliance and increase shareholder value. The objective is to ... governance + Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market...identified issues. + Manage the Complaint Handling process and Medical Device Reporting activities. + Oversee the… more