- Envista Holdings Corporation (Quakertown, PA)
- … regulatory and quality backgrounds that work collaboratively in the fast-paced medical device field. A friendly and open atmosphere helps to foster ... on time, within specification and cost in the regulated medical device industry. The position is responsible...direction. + Partners with Product Management, Service, Training, and Regulatory Affairs to ensure successful preparation for… 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
- University of Pennsylvania (Philadelphia, PA)
- …support. Ensure subjects are educated regarding the protocol specifics and study drugs/ devices . + Assist interventionalists in investigational device trials, ... escorting participants to other testing/procedure areas.. . Coordinate several investigational device trials in the cath lab, instruct and support investigators and… 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
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partnering with Regulatory Affairs in planning, coordination, writing, and execution of ... role, you must possess the following:** + 8+ years' experience in the medical device product development and research field; 5+ years of people and or program… more
- Dentsply Sirona (Lancaster, PA)
- …solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply ... required. + Associate's or Bachelor's degree in Quality Assurance, Regulatory Affairs , or a related field is... roles within a regulated manufacturing environment preferred. + Medical device industry experience is a plus.… 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
- Globus Medical, Inc. (Audubon, PA)
- …technique guides, brochures and other marketing/sales support materials + Partner with Regulatory Affairs in planning, coordination, writing, and execution of ... **the following:** + 5 years' minimum experience in product development in the medical device field, joint reconstruction experience is strongly preferred +… more