- Organon & Co. (Plymouth Meeting, PA)
- …years of industry experience? in R&D functions (eg, Clinical Research, Early Development, Medical Affairs , Pharmacovigilance, Regulatory Affairs , etc.) + ... leading the development or life-cycle management of drugs or devices which improve human health. The program manager may...plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical ,… more
- CSL Behring (King Of Prussia, PA)
- …successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling ... regulatory activities/submissions and 3 years working on developmental products. Previous regulatory affairs experience is preferred. + Experience in working… more
- Olympus Corporation of the Americas (Center Valley, PA)
- … products to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business ... Duties** + Supports supplier quality activities for sourced finished Medical Device products and leads these supplier...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Organon & Co. (Plymouth Meeting, PA)
- …cross-functional interactions with early clinical development, late-clinical development, regulatory affairs , safety and pharmacovigilance, Chemistry, ... Lead will be responsible for ensuring the fulfillment of regulatory requirements and commitments as well as execution of...Manufacturing and Controls (CMC), medical affairs and business development are critical… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …of 6 years of experience. + Prior experience in a sponsor, CRO, or medical device company. In-depth knowledge and experience with FDA regulations and familiarity ... and GCDMP. + Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or combination products). + Excellent… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …areas. + Execute global internal audit activities for the Quality Assurance and Regulatory Affairs Function and tracks and coordinates audit corrective actions ... 15 years of experience in Audit Assurance within the medical device industry with 7 years of...Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Quality & Regulatory Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Minimum of two (2) or more years experience in clinical research, with medical device and/or pharmaceutical trials. + Strong computer skills with proficiency ... domestically up to 10%. **Preferred:** + Previous experience with medical device trials **Why join Olympus?** We...local law. Posting Notes: || United States (US) || Pennsylvania (US-PA) || Center Valley || Medical Affairs… more
- West Pharmaceutical Services (Exton, PA)
- …to human factors, combination products, delivery system and design controls. + Experience in medical device regulatory affairs and/or design control ... Director, Regulatory Affairs Requisition ID: 71273 Date:...Ability to comprehend principles of math, science, engineering, and medical device use. + Ability to handle… more
- West Pharmaceutical Services (Exton, PA)
- … regulatory requests. **Essential Duties and Responsibilities** + Develop and implement medical device regulatory strategies for West's administration and ... through our sustainability efforts. **Job Summary** The Sr. Specialist, Regulatory Affairs , Medical is responsible...5 years of relevant experience + 2+ years of medical device regulatory experience preferred… more
- Globus Medical, Inc. (Audubon, PA)
- …experience in medical device industry or equivalent, preferably within orthopedic medical devices ; Regulatory Affairs experience is a plus. + ... At Globus Medical , we move with a sense of urgency...lives as quickly as possible. **Position Summary** **:** The Regulatory Affairs Associate assists in drafting, submitting… more
