- ThermoFisher Scientific (Pittsburgh, PA)
- …5 years of proven experience in regulatory affairs, ideally within the medical device or pharmaceutical industry. + Strong understanding of FDA regulations, ... Boards of Pharmacy (NABP) regulations. + Organize and validate device data for submission and registration with the FDA...state and international regulations related to medical devices . + Demonstrate ability to maintain regulatory … more
- Dentsply Sirona (York, PA)
- …team. This role develops regulatory strategies for existing, new, and modified medical devices and other (regulated) products. This role manages and submits ... implements regulatory strategies to obtain and maintain regulatory approvals for medical devices ...experience in regulatory affairs, preferably in the medical device industry. + Experience with leading… more
- Globus Medical, Inc. (Audubon, PA)
- … device industry, or equivalent. + Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably ... At Globus Medical , we move with a sense of urgency...as quickly as possible. **Position Summary** **:** The Manager, Regulatory Affairs, is responsible for preparing, filing and gaining… more
- Globus Medical, Inc. (Audubon, PA)
- …or equivalent; Engineering degree is a plus + Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, , preferably within ... their lives as quickly as possible. **Position Summary:** The Regulatory Affairs Specialist assists with drafting, submitting and gaining...orthopedic medical devices ; + Experience in medical … more
- West Pharmaceutical Services (Exton, PA)
- …5 years Bachelor's with 5+ years required; or + Master's degree/PhD 2+ years medical device regulatory experience required **Preferred Knowledge, Skills and ... Sr. Specialist, Regulatory Affairs, Product Stewardship Requisition ID: 69466 Date:...legislations (eg California Prop 65, RoHS, Conflict Minerals, EU Medical Device Regulation) for all West global… more
- Bayer (Indianola, PA)
- …ensure registration of products; + Support international registrations within the Radiology Medical Device Regulatory Affairs group; + Maintain registration ... minds to make a real difference, there's only one choice.** ** Regulatory Specialist Co-Op** **YOUR TASKS AND RESPONSIBILITIES** The primary responsibilities of… more
- Fujifilm (Harrisburg, PA)
- …to Division General Counsel and senior business management on general legal and regulatory risks affecting the Medical Device businesses, including with ... part of the legal team providing support to the Medical Device businesses of FUJIFILM Healthcare Americas...The Senior Counsel, reporting to the Division General Counsel, Medical Devices , will be an experienced commercial… more
- Jabil (West Chester, PA)
- …and foster vibrant and diverse communities around the globe. Are you experienced in Medical Device Regulatory Compliance? Jabil is seeking a qualified ... Quality Systems & Compliance Lead for Medical Device to work in our West..., you will manage, as an individual contributor, all Regulatory Compliance activities at the assigned sites. You will… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA) medical device regulatory requirements, applicable ISO 13485 standard requirements ... of up to 3 Tesla, which could dangerously affect any implanted medical devices made of ferrous material, potentially causing serious injury and/or death.** +… more
- Merck (West Point, PA)
- …Moldings, Management Process, Manufacturing Compliance, Medical Devices , Product Commercialization, Quality Management System Improvement, Regulatory ... managing external partners in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on… more