Description
ESSENTIAL DUTIES* Participation in the development of regulatory strategies and prepare regulatory submissions
* US submissions include IDEs, 510(k)s and PMAs
* 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
QUALIFICATIONS
At least 3-5 years of regulatory affairs experience, most importantly working on PMA submissions. Bachelors degree required, Masters a bonus. Most likely the company cannot transfer an H1B visa.
To find out more about Real please visit www.realstaffing.com