- Actalent (Irvine, CA)
- …to work cross-functionally with departments such as Advanced Operations, Product Development, Regulatory Affairs , and Marketing. + Demonstrated ability to manage ... a crucial role in ensuring the quality and compliance of new medical device products throughout their development lifecycle. You will be responsible for supporting… more
- Terumo Medical Corporation (Somerset, NJ)
- …stakeholders, to include Clinical Affairs , Professional & Clinical Education, Regulatory Affairs , Quality Systems, Marketing, Sales as well as external ... documents and scientific presentations in cooperation with the Clinical, Medical, & Regulatory Affairs Teams, Key Opinion Leaders and physician investigators. +… more
- Actalent (Santa Clara, CA)
- …or Nursing. + 2-3 years of experience in complaint handling, quality assurance, or regulatory affairs within the medical device or pharmaceutical industry. + ... cross-functional teams such as R&D, Manufacturing, and Regulatory . + Determine regulatory reportability and submit Medical Device Reports (MDRs) to the… more
- Envista Holdings Corporation (Quakertown, PA)
- …and product direction. + Partners with Product Management, Service, Training, and Regulatory Affairs to ensure successful preparation for and execution of ... growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced… more
- Medtronic (Newton, MA)
- …workflow and product knowledge. + Collaborate with cross-functional teams, including R&D, regulatory affairs , and clinical teams, to ensure alignment on quality ... improving patient outcomes, you'll have the opportunity to impact global healthcare as the usage of Affera grows rapidly...a relevant field. + Certification in quality systems or regulatory affairs (eg, Six Sigma, ASQ, or… more
- Bausch + Lomb (Clearwater, FL)
- …equipment, or process changes before implementation + Collaborate with Quality and Regulatory Affairs to resolve any discrepancies or nonconformances before ... + Knowledge in Sterilization Process (Steam, Radiation and EO). + Strong grasp of global quality and regulatory requirements including cGMP, ISO 13485, and 21… more
- Edwards Lifesciences (Raleigh, NC)
- …for Medicare Services (CMS) and/or Medicare Administrative Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers. **The Director, Global Health ... with experience collaborating cross-functionally with teams such as Sales, Marketing, Clinical, Regulatory , Legal, and Government Affairs to address economic and… more
- Hologic (Newark, DE)
- …the highest quality. Collaborate with top talent across Clinical Development, R&D, Regulatory Affairs , Program Management, Legal, Marketing, and Operations to ... leading major US and global clinical trials across multiple phases of medical device development. You'll ensure studies are executed on-time, on-budget, and with… more
- J&J Family of Companies (Titusville, NJ)
- …Team leadership via matrix interactions includes individuals from TA strategy, GCSO, global regulatory affairs , project management, finance, legal, quality ... and Device Development and Regulation, Program Management, Regulatory Affairs Management, Relationship Building, Safety-Oriented, Scientific Research,… more
- ConvaTec (Lexington, MA)
- …8 to 10 years of clinical trial management experience in conducting and leading global medical device clinical trials, preferably with a sponsor company. + Solid ... understanding of the device development process, ICH guidelines/GCP and specifically, each step...(Study Management, Site Management, Data Management / Data Analytics), Global Head of Clinical Operations, R&D, Regulatory … more