Regulatory Affairs Director (Head) Medical Device

 

A growing Medical Device company has retained Junto HLS to recruit a Director (Head) of Regulatory Affairs.

Select Accountabilities:

  • The Director designs and implements regulatory strategies
  • Provides regulatory leadership to project teams ensuring the generation of complete and accurate information in support of agency filings
  • Authors and directs the preparation of agency filings and leads critical health authority interactions
  • Reviews and approves promotional materials and product labeling
  • Interprets and advises the company on compliance with existing and/or developing regulations.
  • Ensures Quality Systems adherence and audit readiness
  • Manages project/program risks and communicates effectively with appropriate internal and external stakeholders

Qualifications:

  • Medical Device Regulatory Affairs experience
    • Class II Medical Device and Blood Glucose Monitoring Systems experience a plus
  • Track record of leading the authoring, filing, and successfully negotiation of 510ks
  • Quality Systems implementation and oversight experience
  • Comprehensive knowledge of US (FDA) Medical Device Regulations
  • B.S. or B.A. with an advanced degree a plus

Location(s):

  • Bethesda, MD

If you are open to explore and learn more about this opportunity submit your resume using the button below or send directly to DanFarina@JuntoHLS.com.