- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... outcomes and set new standards of care. **ESSENTIAL DUTIES AND RESPONSIBILITIES:** The Quality Control Technician II will be responsible for performing quality … 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 ... a broad portfolio of on-market medical devices including Software as a Medical Device (SaMD) within the Health Division in Wolters Kluwer. Important… more
- Sanofi Group (Cambridge, MA)
- …(early phase, late stage and marketed products). + Develop innovative and sustainable medical device regulatory strategies covering combination products and ... BS with 10 years regulatory experience. At least 5 years of relevant medical device and/or combination product regulatory experience required. + At least… more
- Takeda Pharmaceuticals (Lexington, MA)
- …multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** ** Device ... liaison to Global Device Team, including engineering, regulatory affairs, quality , and commercial functions +...of experience** + Minimum 5 years of combination product, medical device , or pharmaceutical industry experience +… more
- Medtronic (Newton, MA)
- …and debugging software that interfaces with hardware components. Experience with regulatory compliance and security protocols specific to medical software ... user-friendly interfaces that enhance the usability and functionality of our advanced medical devices. The Senior Software Engineer will be a key player in… more
- Chemours (Boston, MA)
- …Engineering, Biological Science, Toxicology or comparable technical field + 5+ years of medical device regulatory compliance experience with respect to raw ... outside lawyers, consultants, industry associations, and local agencies on specific medical regulatory topics. + Coordinate and review customer… more
- Tecomet (Woburn, MA)
- …facilitate the development of quality systems for a highly regulated medical device , aerospace, defense industries to achieve customer satisfaction, ... identified issues. + Manage the Complaint Handling process and Medical Device Reporting activities. + Oversee the...Fifteen (15) years of regulatory affairs and quality systems experience directly in medical devices… 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
- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... with some complexity. + Demonstrated proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device or IVD space. +… more
- Hologic (Marlborough, MA)
- …and continuous improvement of regulatory compliance for our capital equipment medical device portfolio. Working cross-functionally with R&D, Quality , ... preferred) + 5-8 years' regulatory affairs experience in the medical device industry, ideally with capital equipment products + Proven expertise preparing… more
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