Director of Regulatory Affairs - Hybrid Work Environment
Company: ReShape Lifesciences Inc.
Location: San Clemente
Posted on: November 19, 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. THE ROLEReShape Lifesciences has a
fantastic opportunity for a Director of Regulatory Affairs to join
our growing team. This role is responsible for overall hands-on
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 will
implementation activities to minimize business exposure. WHAT
- 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.).
- 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.
- 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
- Oversee the review of all labeling for compliance with
regulations and ensure that claims are substantiated and
- 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
- Experience in regulatory in medical device industry
- Experience with international submission preparation
- Experience preparing IDE, PMA and 510k submissions
- Experience with review of marketing materials to ensure
- Demonstrated ability to manage and participate in audits and
inspectionsWHAT 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#LI-HybridPI197043498
Keywords: ReShape Lifesciences Inc., San Clemente , Director of Regulatory Affairs - Hybrid Work Environment, Executive , San Clemente, California
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