Senior Regulatory Affairs Specialist
Company: ReShape Lifesciences
Location: San Clemente
Posted on: June 2, 2021
ReShape Lifesciences has a fantastic opportunity for Senior
Regulatory Affairs Specialist to join our growing team. This role
is responsible for providing support to achieve product clearance
and/ or approval in the U.S. and the rest of the world. We are
located in San Clemente, Ca and offer a hybrid work environment.
ESSENTIAL JOB FUNCTIONS (including but not limited to): Prepare and
submit regulatory files and regulatory reports as needed, including
annual PMA reports, PMA submissions, 510(k), Pre-submissions,
technical files, change notification, and international license
renewals. Take a lead role in drafting U.S. and O.U.S. submissions.
Assess product changes and possible regulatory impact and serve as
external standards and compliance expert. Support communication to
FDA and international regulatory agencies, including but not
limited to formal submissions, e-mails, and telephone calls with
reviewers. Support activities associated with maintaining and
revising, as necessary, Regulatory Standard Operating Procedures.
Provide regulatory guidance and evaluation of promotional
activities associated with the Company s products worldwide.
Support internal and external audits (e.g. FDA).
EDUCATION/EXPERIENCE Bachelor s Degree Required 3+ year Regulatory
experience Understanding of U.S. and international regulatory
requirements associated with regulatory submissions.
Keywords: ReShape Lifesciences, San Clemente , Senior Regulatory Affairs Specialist, Other , San Clemente, California
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