Description
Description:A leading global medical device company is seeking a Manager of Regulatory Affairs for their expanding team. The Manager of Regulatory Affairs will work closely with the Director of Regulatory Affairs for product approvals in theU.S., EU and other global markets.
Responsibilities:
- Manages regulatory duties dealing with the development, support, and manufacturing of the Company's medical device products.
- Manages and implements regulatory strategies and plans for timely approvals of novel products
- Reviews and composes labelling and promotional materials for products
- Manages all filing and submission work of 510(k), PMA and/or International registrations
- May have HR function for hiring, interviewing, and performance feedback for direct reports
- Oversees and assesses Regulatory developments related to the Company's products.
Qualifications:
- 5+ Years Regulatory Affairs Experience desired
- Hands-on submissions experience with II/III medical device company
- Experience with 510(k) and/or PMA or International Registrations
- Strong collaborative skills and ability to work well in team settings
- Must have exceptional communication skills, both verbally and written
- Bachelor's Degree (Life sciences or Engineering strongly desired)
To find out more about Real please visit www.realstaffing.com