Description
The desired candidate wil have:- A balanced approach to regulatory judgments.
- Clear and independent thinking.
- A personality that is focused, driven, ambitious and seeks out innovative approaches to challenges.
- A person who thrives in a fast paced, intense culture. A person with high integrity and character, who is tough minded, fair and principled.
- Exceptional communication skills and whose daily actions are culture building.
- The ability to interface effectively with all levels and functions within the organization.
Qualifications:
- 3-7+ years of successful experience with increasingly complex regulatory submissions.
- Direct experience with drafting 510(k) Submissions that were successfully navigated through the approval process at FDA.
Job responsibilities will include:
Participation in the development of regulatory strategies and prepare regulatory submissions
* US submissions include 510(k)s
* EU submissions include filing and amending Technical Files
* Other markets as required
* Creation, review and approval of labeling
* Approved labeling, including IFUs, packaging, etc.
* Promotional labeling, including advertisements, promotional pieces and professional education materials
* Reporting
* Medical Device Reports (MDRs)
* EU vigilance Reporting
* Represent Regulatory Affairs on various cross-functional teams:
* Corrections and Removals
To find out more about Real please visit www.realstaffing.com