Director of Regulatory Affairs – Hybrid Remote Environment
Company: ReShape Lifesciences Inc.
Position: Director of Regulatory Affairs
Posted: October 3, 2022
ReShape Lifesciences Inc. is America’s premier weight-loss solutions company, offering an integrated portfolio of proven products and services that manage and treat obesity and metabolic disease. Our team is driven by a passion to help patients learn how to make long-term healthy living a part of their everyday lives. Our portfolio includes the FDA-approved Lap-Band® program, the investigational ReShape Vest™ System and the recently launched reshapecare™ virtual health coaching program.
Join us as we partner with clinicians to implement our innovative, non-invasive weight loss procedure and one-on-one support that helps inspire patients on their journey towards successful, long-lasting weight loss.
We are located in beautiful San Clemente, California, and offer a hybrid work environment.
ReShape Lifesciences has a fantastic opportunity for a Director of Regulatory Affairs to join our growing team. 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.
WHAT YOU’LL DO
- 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.).
WHAT YOU’LL NEED
- 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
WHAT WE OFFER
- 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