- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- …510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical device regulations and lead the development ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will represent...change control, ensuring compliance with US, EU, and other global regulatory requirements. + Author FDA submissions… more
- Insight Global (Lebanon, TN)
- Job Description This client is a leading innovator in the medical device industry, dedicated to improving patient outcomes through cutting-edge technology and ... SmartDrive MX2+ project, ensuring all documentation and processes meet current regulatory and internal quality system requirements. This person will be responsible… more
- Abbott (Santa Clara, CA)
- … device regulations and guidelines, and product and therapeutic area knowledge to support Regulatory Affairs medical device submissions in the EU for CE ... Abbott is a global healthcare leader that helps people live more...clinical research, clinical affairs , regulatory affairs , or quality systems, in the medical device… more
- Cook Medical (Bloomington, IN)
- …Division, Marketing, company Functions, and Operational Units (including R&D, Regulatory Affairs , Quality Assurance, Quality Engineering, Engineering, ... in our Vascular Divsion. Assist in the development, and communication, of the global strategy for the assigned product line(s), and lead execution in alignment with… more
- J&J Family of Companies (Irvine, CA)
- …of innovation pipeline, working collaboratively with R&D, Regulatory , Clinical Affairs , and other functions. + Lead Global portfolio strategy, positioning, ... https://www.jnj.com/medtech **We are searching for the best talent for a Director, Global Strategic Marketing, Refractive Equipment Portfolio to join our J&J Vision… more
- Abbott (Santa Clara, CA)
- …and Launch Plans + Partner with cross-functional teams such as upstream marketing, regulatory affairs , clinical, R&D, and legal to plan andexecute on strategies ... Abbott is a global healthcare leader that helps people live more...the success in the roles. **Preferred Qualifications** + Medical device experience is preferred. + Experience with advertising and… more
- Olympus Corporation of the Americas (Westborough, MA)
- …deliverables from assigned projects as required by the SDLC and will support Regulatory Affairs ' efforts in creating submission materials for various ... Interacting with a diversity of disciplines such as R&D, Quality Engineering, Regulatory Affairs , etc. + Independent organizational and time management skills… more
- BD (Becton, Dickinson and Company) (San Diego, CA)
- …RAC certification preferred). + 10+ years of progressive experience in Quality Assurance and Regulatory Affairs within the medical device or SaMD (Software ... standards. + ** Regulatory Guidance and Frameworks** : Closely work with Regulatory Affairs team to define and own the development of industry-specific… more
- Abbott (Plymouth, MN)
- …Operations, Risk Management, Reimbursement, Medical Affairs , Quality, and Regulatory Affairs . You will also interact with global regulatory agencies ... Program Management, Reimbursement, Medical Affairs , Risk Management, Quality and Regulatory Affairs , and investigational sites. + Oversee study Steering… more
- J&J Family of Companies (Irvine, CA)
- …partners including but not limited to R&D, Clinical Research, Business Development, Regulatory Affairs , Quality & Compliance, Health Economics & Market Access, ... impact health for humanity. Learn more at https://www.jnj.com **Job Function:** Medical Affairs Group **Job Sub** **Function:** Medical Affairs **Job Category:**… more