Principal Regulatory Affairs Specialist

Minnesota  ‐ Onsite
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Keywords

Description

Description:

A leading global diagnostics company is seeking a Principal Regulatory Affairs Specialist for their growing Regulatory development team. The Principal Regulatory Affairs Specialist will work closely with the Director of Regulatory Affairs for product approvals across theUnited StatesandEurope, as well as other International 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, submissions, and all pertaining to products strategy

- Manages and oversees all filing and submission work of 510(k), PMA and/or International registrations

- Manages and directs Regulatory development, review, and composition related to the Company's products.

Qualifications:

- 5-7 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 and cross-functional work with other regulatory teams

- Bachelor's Degree (Life sciences or Engineering strongly required)

To find out more about Real please visit www.realstaffing.com
Start date
05/2013
From
Real Staffing
Published at
05.05.2013
Project ID:
531936
Contract type
Permanent
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