Remote Regulatory Affairs Senior Director

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Tue, May 31, 2022
Job Summary

A healthcare research company is searching for a person to fill their position for a Remote Regulatory Affairs Senior Director.

Core Responsibilities of this position include:

  • Leading regulatory contact for FDA, Health Authority negotiations on GRAIL MCED products
  • Providing regulatory support towards new and currently marketed products
  • Assessing impact of new regulations and work with cross-functional partner

Skills and Requirements Include:

  • B.S./B.A. in a science or related life science field
  • Minimum of 12 years’ experience in regulatory, R&D, clinical affairs, and quality in IVD
  • Experience with regulatory submissions for PMA, IDE and CE Mark
  • Track record of leadership, providing sound regulatory judgment/ideas
  • Experience with Microsoft based applications and general knowledge of PC functions necessary
  • Ability to interpret and respond to requests from regulatory agencies
COMPLETE JOB DESCRIPTION

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