Job Title: Director of Regulatory Affairs
Austin Vita is delighted to support a premier weight-loss solutions company based in Orange County who is hiring for a Director Regulatory Affairs to join a growing team. Located in San Clemente, this position offers a hybrid work environment.
This role is responsible for overall management and direction of the Regulatory Affairs department to assure achievement of business objectives and government compliance. The Director of Regulatory Affairs will proactively evaluate existing and emerging regulatory requirements and direct implementation activities to minimize business exposure.
A great fit would be someone who has exceptional leadership, enjoys working in a highly-collaborative, cross-functional environment and has excellent communication.
- Oversee the Regulatory Affairs department, including providing strategy and guidance to meet company objectives and FDA and international guidance and regulations.
- Direct regulatory strategy development for government submissions and incorporate into product development plans.
- Plan, coordinate and execute Class II and Class III regulatory submissions as appropriate and hold sign-off responsibility to obtain and sustain commercial approval.
- Prepare for and oversee all regulatory audits (internal, ISO, FDA, EUMDR, supplier, etc.).
- Ensure organizational compliance with domestic and international regulations, standards and requirements.
- Act as regulatory expert and support cross-functional teams to identify, achieve and maintain compliance with applicable standards.
- Oversee the review of all labeling for compliance with regulations and ensure that claims are substantiated and sustained.
- Review complaint reports to determine, complete and communicate required reporting in accordance with US and international regulations (i.e., US MDR, EU vigilance, Canadian MPR, etc.)
- Serve as regulatory liaison with designated regulatory bodies on behalf of ReShape Lifesciences (Notified Body, FDA, PRRC, Advisory Panel meetings, etc.).
- Bachelor's Degree in technical field or scientific discipline required
- Experience in regulatory in medical device industry
- Project management experience
- Experience with international submission preparation
- Experience with implantable medical devices
- Experience preparing IDE, PMA and 510k submissions required
- Experience with EU MDR and ISO13485 required; experience with other international regulations preferred
- Experience with review of marketing materials to ensure regulatory compliance
- Demonstrated ability to manage and participate in audits and inspections
- Hybrid work environment
- Business casual dress code
- Corporate-sponsored virtual team building events
- Medical, dental, vision and life insurance
- FSAs, HSAs, long-term and short-term disability
- 401(k) plan
- Employee assistance plan (EAP)
- Employee Stock Options