- Philips (Cambridge, MA)
- …design changes, and field safety corrections, with a primary focus on Software as a Medical Device (SaMD) for our Sleep & Respiratory Care products in the US, ... a minimum of 7+ years' experience in Regulatory Affairs/Strategy within FDA regulated Medical Device environments. + You have proven expertise in Software as… more
- Olympus Corporation of the Americas (Westborough, MA)
- …degree in life sciences or related field. + Minimum of 10 years medical device industry experience post-degree preferably in Clinical Research, Clinical ... Partners with cross-functional teams including Clinical Research leadership, legal, compliance , medical ,and finance to facilitate seamless study...Development or Medical Affairs within the medical … more
- Cognizant (Boston, MA)
- …outcomes such as: + Energy savings + Equipment uptime + Food safety compliance + Reduced maintenance costs **Key Responsibilities** + Architecture & Design: Define ... site-level reference architectures, standardize device selections, and communicate complex technical concepts clearly to non-technical stakeholders. + Implementation… more
- Sanofi Group (Framingham, MA)
- …framework, providing expert guidance on Chemistry, Manufacturing, and Controls (CMC) and medical device regulatory requirements across the product lifecycle. Our ... accelerate progress. As GRA CMC Lead within our GRA CMC & GRA Device Organization, you'll drive global regulatory strategies for pharmaceutical and vaccine products,… more
- Candela Corporation (Marlborough, MA)
- …/ regulatory / compliance . . Working understanding of relevant global/regional medical device regulations and standards with particular emphasis on MDSAP, ... Degree in engineering or related field, plus 15 years of related experience in the medical device industry with at least 12 years in a management/leadership role… more
- Guidehouse (Boston, MA)
- …Life Sciences practice is an engine of innovation, helping pharmaceutical, biotech, medical device , and diagnostic companies develop custom solutions that tackle ... provides commercialization strategy and market access services to pharmaceutical, biotechnology, medical device , and diagnostics companies. Our client services… more
- Oracle (Boston, MA)
- …secure integration with monitoring and alarm systems, and ensure continual compliance with both Oracle's and external regulatory requirements. You will collaborate ... with data center engineering teams, vendors, compliance managers, and security operations to deliver seamless, reliable, and auditable rack-level protection across… more
- Amgen (Boston, MA)
- …Bachelor's Degree and 3 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience OR Associate degree and ... changing environment and results. + Adheres to the Company's compliance policies and guidelines as well as any other...6 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience… more
- Amgen (Boston, MA)
- …Bachelor's Degree and 3 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience OR Associate degree and ... changing environment and results. + Adheres to the Company's compliance policies and guidelines as well as any other...6 years of sales experience within pharmaceutical, biotech or medical device industry or hospital sales experience… more
- Olympus Corporation of the Americas (Westborough, MA)
- …21 CFR 820 and ISO 13485 required. + Working knowledge of international medical device quality system requirements required. + Complete understanding and ... to take evening and early morning teleconferences. **Preferred:** + MBA Preferred. + Medical Device Experience preferred + Black Belt Certification preferred. +… more