Senior Regulatory Affairs Specialist
Company: ReShape Lifesciences Inc.
Location: Irvine
Posted on: March 21, 2023
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Job Description:
Job Description:
Job Description 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. THE
ROLE 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 DOPrepare 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 NEEDBachelor's Degree with experience in the medical device
industryMinimum 4 years of work experience in the medical device
industryDemonstrated understanding and application of U.S. and
international regulatory requirementsAbility to efficiently
process, organize and evaluate incoming data to ensure that proper
and immediate action is taken WHAT WE OFFERHybrid work
environmentHalf-FridaysBusiness casual dress
codeCorporate-sponsored virtual team building eventsMedical,
dental, vision and life insuranceFSAs, HSAs, long-term and
short-term disability401(k) planEmployee assistance plan
(EAP)Employee Stock Options #LI-Hybrid PI207149251
Keywords: ReShape Lifesciences Inc., Irvine , Senior Regulatory Affairs Specialist, Other , Irvine, California
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