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