Senior Regulatory Affairs Specialist
Company: ReShape Lifesciences Inc.
Posted on: January 22, 2023
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 offer a flexible work environment.
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
Prepare worldwide regulatory files and regulatory reports for new
products and product changes, including annual reports,
submissions, technical documentation and more.
Take lead roll on drafting US and international submissions.
Directly communicate with the FDA, international regulatory
agencies, Authorized representative(s) and European Importer,
including but not limited to formal submissions, e-mails and
telephone calls with reviewers.
Prepare and review regulatory strategies with leadership team and
negotiate submission steps with regulatory bodies, as needed.
Work closely with Research and Development and other
cross-functional teams to evaluate proposed changes to product
design and development and assess impact of the proposed changes on
worldwide approvals and company policies and procedures.
Provide regulatory guidance and evaluation of promotional
activities associated with the Company's products worldwide.
Develop and maintain association with outside organizations and
institutions pertinent to the interests and needs of the department
and the Company.
Support both internal and external audits (e.g. FDA).
WHAT YOU'LL NEED
Bachelor's Degree with experience in the medical device
Minimum 4 years of work experience in the medical device
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
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
Employee assistance plan (EAP)
Employee Stock Options
Keywords: ReShape Lifesciences Inc., Irvine , Senior Regulatory Affairs Specialist, Other , Irvine, California
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