Associate Director Regulatory Affairs
| Company | Becton Dickinson |
|---|---|
| Location | San Diego, CA, USA |
| Salary | $Not Provided – $Not Provided |
| Type | Full-Time |
| Degrees | Bachelor’s |
| Experience Level | Senior, Expert or higher |
Requirements
- Bachelor’s degree in a scientific discipline: Engineering, Biology, etc. or equivalent.
- Minimum 10 years of relevant work experience including experience within the Medical Device industry.
- Minimum of 5 years of experience in Regulatory Affairs working with complex medical device systems and software strongly preferred.
- Experience working with external service providers, consultants, and regulators required.
- Ability to travel up to 20% domestically and internationally may be required.
Responsibilities
- Lead submission activities for various initiatives
- Work closely with cross-functional teams on submission strategy and documentation development for new product submissions
- Coordinate interactions between internal stakeholders and external service providers to ensure timely completion of submission milestones.
- Assist in the maintenance of departmental systems used to track projects and ongoing operational activities.
- Directly interface with regulators as needed.
- Perform additional tasks as required.
Preferred Qualifications
- Advanced degree (Master’s degree or higher) preferred.
- Regulatory Affairs Certification (RAC) preferred.
- Project Management Certification preferred.
- Familiarity with Infusion Pump Systems preferred.