Description
A Global medical device company is seeking a Director or Senior Director of Regulatory Affairs, and is responsible for interpreting U.S. FDA medical device regulations and establishing regulatory plans for obtaining worldwide regulatory approval. The ideal candidate will have United States Regulatory Affairs experience with both 510(k) and IDE background, strong submission strategy and writing, people management capability, and experience working with the EU.PRIMARY RESPONSIBILITIES:
- Management role responsible for the Company's regulatory affairs and regulatory compliance activities
- Represent Regulatory Affairs on project team and management meetings
- Provide management and leadership to the Regulatory Affairs organization in the development and implementation of strategies and processes
- Review advertising, labeling and public communications
- Review and approve change orders and software change orders
- Responsible for worldwide regulatory filings, includingU.S., EU and other international markets
- Provide training, and mentoring to company personnel regarding regulatory strategies
- Act as company representative with US and International regulatory authorities
- Assist in ensuring compliance to the Medical Device Directive (MDD) in the EU, Canadian Medical Device Directive
JOB REQUIREMENTS:
- 10+ Years experience in Regulatory Affairs (Device required)
- BA degree (scientific field a plus)
- Proven experience with at least 10 years interacting with regulatory agencies
- Hands-on experience with the preparation and submission of some or all of the following regulatory documentation, including 510(k) and PMA
- Must have exceptional communication skills, both verbal and written, as well as excellent interpersonal skills.
- Must be detail oriented, well organized and able to work independently and in teams
- Must have people management experience
- Experience working with EU
To find out more about Real please visit www.realstaffing.com