Description
A leading research-focused healthcare group, in the diagnostics space is seeking qualified individuals to join their regulatory affairs team. With continual organizational growth and strong pipeline, their regulatory affairs team is looking to bring in a new regulatory affairs principal specialist or manager.The Position:
- Manages regulatory responsibilities associated with the development, support, and manufacturing of the Company's medical device products.
- Manages and develops regulatory strategies and plans to for timely approval of new products
- Reviews labeling
- Manages filing and submissions of 510(k), PMA and/or International registrations
- May have HR function for hiring, interviewing, performance feedback, etc.
- Monitors and assesses Regulatory developments related to the Company's products.
Qualifications:
- 4+ Years Regulatory Affairs Experience
- Hands-on submissions experience with IVD or class II/III medical device company
- Experience with 510(k) and/or PMA and/or BLA or International Registrations
- Must be collaborative and work well in team settings
- Must have strong communication skills, both verbally and written
- Bachelor's Degree (Lifesciences or Engineering strongly preferred)
To find out more about Real, please visit www.realstaffing.com