- 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
- Pfizer (Collegeville, PA)
- **ROLE SUMMARY** The Medical Digital Health Lead, Sr . Director plays a pivotal role in closing care gaps through Medical digital innovation. This individual ... Medical Digital Health portfolio (eg, Software as a Medical Device ) This role will work in close collaboration with...medical risk & benefits analysis which are presented to senior leadership for discussion and funding decisions. + Develop… 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
- CSL Behring (King Of Prussia, PA)
- **Summary of Role** Reporting to the Senior Director Global Business Development and Licensing, this role is responsible, on a global basis, for business ... meetings aligned with CSL's commercial growth strategy. + Working with the Senior Director , Global Business Development, lead the continued evolution and… more
- J&J Family of Companies (Spring House, PA)
- …R&D area with demonstrated organizational awareness and applied knowledge of end-to-end (E2E) drug or medical device development is required. + A minimum of ... Johnson & Johnson Innovative Medicine is recruiting for a Director , Submission Program Management Leader. This position can be...scope and gain alignment on Submission North Star with Senior Leadership. + Lead planning and execution of the… 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