Description
DescriptionA leading global medical device company is seeking a Manager of Regulatory Affairs for their expanding team. The Manager of Regulatory Affairs will work with the Director of Regulatory Affairs towards timely product approvals in theU.S., EU and other international markets.
Responsibilities
- Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products.
- Manages and develops regulatory strategies and plans for timely approval of novel products
- Reviews labelling and promotional materials for submissions
- Manages filing and submissions of 510(k), PMA and/or International registrations
- HR function for hiring, interviewing, and performance analysis for direct reports
- Monitors and assesses Regulatory protocols related to the Company's products and procedures.
Qualifications
- 6+ Years Regulatory Affairs Experience
- Hands-on submissions experience with class II and III medical devices
- Experience with 510(k) and/or PMA or CE Marks
- Must have strong communication skills, both verbally and written
- BS in Lifesciences strongly preferred
To find out more about Real please visit www.realstaffing.com