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Sr. Regulatory Affairs Specialist
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.
HYBRID WORK ENVIRONMENT – TYPICALLY IN THE OFFICE ONE DAY PER WEEK.
ReShape Lifesciences has a fantastic opportunity for a Senior Regulatory Affairs Specialist to join our growing team. This role is responsible for supporting product clearance and/or approval in the U.S. and the rest of the world. This position will hold a lead role in supporting project teams with regulatory review and document review, in addition to other Regulatory duties, such as reviewing promotional materials and providing input related to FDA and other regulatory body submissions.
A great fit would be someone who has a desire to assist in ongoing regulatory support for both commercial and investigational devices in the United States and internationally, enjoys working as part of a cross-functional team and is able to work independently while maintaining a high-level of detail.
WHAT YOU’LL DO
- Take lead role in regulatory submissions; prepare and process regulatory submissions, such as PMA submissions, Annual Reports, IDEs, Premarket Notifications/510(k), Pre-submissions, EU technical documentations, Notified Body change notifications, and ROW submissions, to ensure timely approval.
- Prepare and review regulatory strategies with leadership team and negotiate submission steps with regulatory bodies, as needed.
- Collaborate with cross-functional teams to assess proposed product changes and possible impact with regards to worldwide approvals; determine required regulatory actions (i.e., change submission for pre-approval, etc.).
- Serve as the Regulatory subject matter expert and provide regulatory inputs in cross-functional activities, including but not limited to standards and compliance assessments, design reviews, risk management reviews, post-market surveillance reviews.
- Directly communicate with regulatory bodies (i.e., the FDA), including formal submissions, e-mails and telephone calls with reviewers.
- Review product labeling to ensure compliance with all applicable regulatory requirements.
- Provide regulatory guidance and evaluation of advertising, promotional, and marketing materials to ensure compliance to all applicable regulatory requirements.
- Support both internal and external audits (e.g., FDA and Notified Body audits).
- Other duties and tasks as assigned.
WHAT YOU’LL NEED
- Bachelor’s Degree with experience in the medical device industry
- Minimum 4 years of work experience in the medical device industry
- Demonstrated understanding and application of U.S. and international regulatory requirements
- Ability to efficiently process, organize and evaluate incoming data to ensure that proper and immediate action is taken
WHAT WE OFFER
- Flexible work environment
- Business casual dress code
- Medical, dental, vision and life insurance
- FSAs, HSAs, long-term and short-term disability
- 401(k) plan
- Employee assistance plan (EAP)
- Employee Stock Options
Job posted: 2023-05-16