- Merck (West Point, PA)
- …in technical transfer processes while aligning with the company's business objectives. The Senior Director will ensure device working groups and staff ... **Job Description** The Senior Director of Process Integration and...+ Minimum of 15+ years of experience in medical device or combination product engineering, with significant experience in… more
- Merck (West Point, PA)
- **Job Description** The Senior Director of Device Product Stewardship will lead a department of up to 15-20 personnel overseeing technical support and ... product stewardship for our company's medical device and combination products (approximately 15 in total). This...and statistically sound CAPA plans and issue resolution. The Senior Director will ensure stewards have the… more
- Merck (West Point, PA)
- …Product & Process Development (DPPD) Team designs, develops, and commercializes novel biologic/ drug /vaccine - device enabled combination products to achieve safe ... and launches. **Principal Responsibilities** + Lead and set direction for the device development strategy for multiple drug - device combination product… more
- Integra LifeSciences (Princeton, NJ)
- …treatment pathways to advance patient outcomes and set new standards of care. The Senior Director is responsible for leading the program management of Integra's ... and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …and their amendments/supplements). + Understanding of scientific principles and regulatory Device requirements relevant to global drug development and ... + Preferred experience includes reviewing, authoring, or managing components of both drug and device regulatory submissions. + Understands and interprets… more
- Integra LifeSciences (Princeton, NJ)
- …and Drug Administration regulations, ISO 13485, the Canadian Medical Device Regulations (CMDR), the EU Medical Device Regulation, Japanese Pharmaceutical ... patient outcomes and set new standards of care. **SUMMARY DESCRIPTION** The Director , Supplier Controls is the Compliance Master Plan (CMP) Quality Management System… more