- J&J Family of Companies (Danvers, MA)
- …Officer. The MSO will build clear and strong relationships between Medical Affairs , R&D, Quality, Regulatory , Clinical, Epidemiology to allow for proactive ... and safety communications. + Stakeholder Collaboration: Work closely with Medical Affairs , R&D, Quality, Regulatory , and other cross-functional teams to… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …current GMP, quality principles, and regulatory expectations to support relevant global regulatory submissions. + Authors, reviews and edits CMC sections and ... Collaborates with other external functions on CMC matters (eg, Quality, Commercial, Regulatory Affairs , etc.). Ensures the CMC function is adequately represented… more
- West Pharmaceutical Services (Williamsport, PA)
- …and manages quality control, quality assurance, quality systems, metrology and/or regulatory affairs , personnel, department resources, and continuous improvement ... device manufacturing. **Preferred Knowledge, Skills and Abilities** + ** Regulatory Skills:** In-depth knowledge of medical device ... / Pharmaceutical audits. + Able to interact with global Medical Device / Pharmaceutical agencies in… more
- Actalent (Irvine, CA)
- …of navigating complex situations and collaborating effectively with cross-functional teams, including Regulatory Affairs (RA) and Clinical Affairs (CA). . ... activities for a strategic M&A initiative in the medical device industry. This role demands a strong leader capable...in M&A environments is preferred. + Experience coordinating with Regulatory Affairs and Clinical Affairs … more
- Olympus Corporation of the Americas (Center Valley, PA)
- …to ensure products meet current Good Manufacturing Practices, applicable medical device regulatory requirements, and for supporting business development ... roles and responsibilities of Quality Assurance. + Practical understanding of global regulatory /quality standards and requirements. + Potential for travel… more
- embecta (Parsippany, NJ)
- … changes, internal audits, or process improvements. + Ensure documentation adheres to global medical device regulatory requirements, including FDA 21 CFR ... to enhance efficiency and compliance. + Collaborate with Quality, Manufacturing, Marketing, Medical Affairs , R&D, and Regulatory Affairs teams to ensure… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Medical and Scientific Affairs group, an integral delivery unit within the Global Clinical Affairs organization, the Sr. Clinical Data Manager is accountable ... and completeness of clinical trial data in compliance with regulatory standards, SOPs, and Good Clinical Data Management Practices...+ Strong expertise in implementing and maintaining systems for global medical device trials (Class II/III or… more
- AbbVie (North Chicago, IL)
- …In Licensing relationships, or Co-Marketing relationships. Develops in concert with Regulatory Affairs , the appropriate regulatory strategies for ... Supply Chain, Domestic and International AbbVie Plants and Affiliates, Regulatory Affairs , Research and Development. Additional Information Applicable only… more
- Dentsply Sirona (Charlotte, NC)
- …dentistry, research and/or clinical studies. + 3+ years prior experience in clinical affairs , regulatory affairs , and/or clinical research for AI/ML enabled ... advance patient care and deliver better and safer dentistry. Dentsply Sirona's global headquarters is located in Charlotte, North Carolina, USA. The company's shares… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …Manufacturing. Demonstrates knowledge to provide design documentation to support global Regulatory filing strategies. Applies basic statistical techniques ... alongside Manufacturing and Operations, and provide design documentation to support global Regulatory filing strategies + Execute design verification testing… more