- Otsuka America Pharmaceutical Inc. (Harrisburg, PA)
- …degree and 15+ years of experience in a FDA regulated pharmaceutical and/or medical device industry environment + Strong knowledge of current global Good ... and follow-up of internal and external audits to ensure compliance with regulatory requirements. + ** Regulatory...Previous experience of working in the global pharmaceutical and medical device industry. + Experience working with… more
- Envista Holdings Corporation (Quakertown, PA)
- …Travel: Up to 10%, as needed. **PREFERRED QUALIFICATIONS:** + MS degree preferred. + Medical device design and compliance experience. + Compliance ... regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster… more
- Guthrie (Sayre, PA)
- …has broad oversight responsibilities across core domains: + Clinical Research Operations in compliance and in regulatory areas. + Supports research and scholarly ... administrative executive to collaboratively lead the strategic, operational, and compliance functions of DGF. This role is central to...activities related to Graduate Medical Education (GME), encompassing residents, fellows and … more
- Bausch + Lomb (Harrisburg, PA)
- …departments (eg, R&D/Project Management, Clinical/ Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, Pharmacovigilance/GPSS and Drug/ Device ... clinical trials management (including site monitoring), scientific methods, research design, regulatory compliance , and clinical data management. + Minimum 10-12… more
- Teleflex (Wyomissing, PA)
- …* Minimum of 3 years of previous experience in related field (eg medical device design and manufacturing, or similar regulated industry, plastic processing, ... of Design for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design. * Understanding of verification and validation… more
- Teleflex (Wayne, PA)
- …with FDA's Quality System Regulation (QSR), ISO13485, the Canadian Medical Device Regulations, and all other international regulatory requirements with which ... Medical Director, Interventional Urology and Urology Care (REMOTE)...:12406 **About Teleflex Incorporated** As a global provider of medical technologies, Teleflex is driven by our purpose to… more
- Penn Medicine (Philadelphia, PA)
- …guidance around the implementation of medical devices and managing our Medical Device Cyber Security program. Candidate must have practical CE experience ... + The Clinical Engineer is a corporate resource that provides technical support of medical device systems throughout the HealthSystem. The Architect helps in the… more
- Globus Medical, Inc. (Audubon, PA)
- …for this role, you must possess the following:** + 8+ years' experience in the medical device product development and research field; 5+ years of people and or ... At Globus Medical , we move with a sense of urgency...in industry for this group + Overseeing all Quality Compliance activities for products within department including complaint, CAPA,… more
- Philips (New Kensington, PA)
- …and issue resolution through robust tracking and reporting mechanisms. + Ensure regulatory compliance with FDA design controls and global standards; manage ... Minimum of 8+ years of professional experience in product/solution development within FDA-regulated medical device or technology sectors. + Minimum of 8+ years… more
- Merck (West Point, PA)
- …Understanding of technical interdependencies across Drug Substance, Drug Product, Device , Packaging, Analytical, Regulatory , Quality, and Supply Chain ... mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen… more