Objective:

Will have a broad spectrum of responsibilities spanning from participation in label review, product development teams and preparation of global regulatory submissions.

 

Essential Duties and Responsibilities

  1. Prepare and maintain Technical Files in support of global submissions.
  2. Prepare and submit submissions to obtain global approval.
  3. Review labeling and labels for compliance with regulatory requirements.
  4. Review, assess and provide input to Change Orders; assessing the requirements for regulatory submissions.
  5. Participate and provide Regulatory strategy in product Design Control teams.
  6. Prepare and submit annual reports and license renewals to the FDA and other International regulatory agencies, including coordinating and managing a multi-disciplinary team assigned to provide technical input and expertise for sections of the reports.
  7. Provide regulatory input for ways in which to position a product or a change to an existing product in order to gain regulatory approval in country (ies) for company commercialization.
  8. Review, assess and provide input into Standard Operating Procedures (SOPs) to ensure regulatory compliance.
  9. Manage regulatory files/database and chronologies.
  10. Support product complaint investigations.

 

EDUCATION REQUIREMENTS:

  • Bachelor’s Degree

 

EXPERIENCE REQUIREMENTS:

  • 7-9 years’ experience within the Regulatory Affairs discipline and/or training; or an equivalent combination of education and experience
  • Proven ability to successfully manage multiple projects in a dynamic environment.
  • Willingness to “roll up sleeves” to perform at all levels and assist in areas outside of core responsibilities.
  • Strong strategic thinking and analytical skills.
  • Experience with Class III devices strongly desired.
  • International regulatory experience is a plus.

 

Please send resume to careers@sunevamedical.com and reference Senior Regulatory Affairs Specialist in the subject line.