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.