SR. Regulatory Affairs Specialist - HYBRID

Company: Reshape Lifesciences
Location: San Clemente
Posted on: May 23, 2023

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. HYBRID WORK ENVIRONMENT - TYPICALLY IN THE OFFICE 1 DAY PER WEEK 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 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 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
    • Hybrid work environment
    • Half-Fridays
    • 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
      
      PI

Keywords: Reshape Lifesciences, San Clemente , SR. Regulatory Affairs Specialist - HYBRID, Other , San Clemente, California