- Fujifilm (Boston, MA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...respect to healthcare regulatory compliance , anti-kickback statutes, the False Claims Act, US government… 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
- Integra LifeSciences (Braintree, MA)
- …preferred. + 5+ years GMP/GLP laboratory experience in a medical device , pharmaceuticals, Quality/ Regulatory Compliance , or other regulated industry + ... of new or improved quality control systems as needed. + Ensure compliance with industry regulations, company policies, and safety standards during the transition… more
- Integra LifeSciences (Braintree, MA)
- …discipline. + 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. **ESSENTIAL DUTIES AND… 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
- Tufts Medicine (Boston, MA)
- …to clinical investigations and trials. 3. Ensure preventive maintenance is performed by Medical Engineering in compliance with regulatory requirements. 4. ... Ventricular Assist Devices (VADs) and VAD-related equipment. Responsible for device tracking, supply utilization and ordering, preventative maintenance, coordinating… more
- Fresenius Medical Center (Lexington, MA)
- …regulations. * Maintains corporate regulatory files including EU technical files/documentation ( Medical Device Directives & Medical Device ... Reviews and approves Engineering Change Orders in accordance with regulatory requirements. * Participates in compliance related...as a Regulatory Affairs Specialist in the medical device field or (ii) a Master's… more
- Medtronic (Boston, MA)
- …of relevant experience **Nice to Have: Preferred Qualifications** + 7+ years of medical device regulatory affairs with roles showing increasing ... to labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance . + Monitor, evaluate, and enhance regulatory… more
- Hologic (Marlborough, MA)
- …science related field preferred. + A minimum of 8 years of experience in Regulatory Affairs within the Medical Device industry. + Experience ... streamline and enhance efficiency. + Promote a culture of compliance , collaboration and continuous improvement within the regulatory...proficiency working within a QMS. + Firm understanding of regulatory challenges in the medical device… more