- West Pharmaceutical Services (Williamsport, PA)
- …Skills and Abilities** + ** Regulatory Skills:** In-depth knowledge of medical device and pharmaceutical regulations and guidelines, including cGMP, ICH ... and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs , personnel, department resources, and continuous improvement… more
- Edwards Lifesciences (Irvine, CA)
- …cross-functional partners including Delivery System R&D, Manufacturing, Quality Engineering, Regulatory Affairs , and Clinical Development to ensure alignment ... of our revenue towards research and development to drive and develop groundbreaking medical innovations for structural heart disease. As part of our R&D Engineering… more
- Cook Medical (Bloomington, IN)
- Overview The Senior Packaging Engineer uses their experienced in medical device packaging to design and develop solutions for new and modified products. This ... packaging activities with a cross-functional team including SBU Product Management, Regulatory Affairs , Operations, Quality Assurance, Clinical Affairs ,… more
- Olympus Corporation of the Americas (Westborough, MA)
- …life sciences or related field. + Minimum of 8 years medical device industry experience post-degree preferably in Clinical Affairs /Operations, Medical ... and Marketing, R&D, PMO, HEMA, Risk Management, Quality and Regulatory Affairs , and investigational sites. + Ensures...or local law. Posting Notes: || United States (US) || Massachusetts (US-MA) || Westborough || Medical Affairs… more
- Takeda Pharmaceuticals (Boston, MA)
- …and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs , Quality Assurance, Medical Affairs , ... the Company-wide patient safety expert for assigned pharmaceutical / biological / drug- device combined products, accountable for the safety strategy and major safety… more
- J&J Family of Companies (Titusville, NJ)
- …publications emerging from the Team and its affiliates + Assists Regulatory Affairs in the development of drug/ device regulatory strategies and ... interactions also includes individuals from project management, TA strategy, global regulatory affairs , finance, legal, quality assurance, quality monitoring &… more
- J&J Family of Companies (Santa Clara, CA)
- …impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Professional Medical ... Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated… more
- Terumo Medical Corporation (Elkton, MD)
- …TMC is part of Tokyo-based Terumo Corporation; one of the world's leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide ... Pharmaceutical Affairs Laws, the Canadian Quality System Regulation, and the Medical Device Directive. **Job Details/Responsibilities** + Manage a team of… more
- Stryker (Denver, CO)
- …Bachelor's degree * 10+ years of work experience required * 7+ years medical device or marketing/sales experience preferred * Experience developing strategic ... working with Surgeons, KOL or Clinical influencers **Preferred** + 5+ year in sales or medical education in the medical device industry + People leadership… more
- BD (Becton, Dickinson and Company) (Salt Lake City, UT)
- …and develop **use-related risk analysis (URRA)** and mitigation strategies in partnership with Medical & Regulatory Affairs . + Collaborate with ** ... Validation &** **Human Factors strategies** for successful submission in concert with Regulatory Affairs . + Conduct **gap analyses** of existing DVal/HF… more