home >> medical / pharmaceutical >> job board >> post

Posted by: CCSI, Inc <Jason@ccsiinc.com> on March 06, 2013 at 07:00:30. Click here to reply to this post via Email.

Contract / Temp to Direct / Direct Hire: Contract
City: Tempe
State: Arizona
Country: United States
Zip or Postal Code: 85281

6042 Sr. Regulatory Affairs Specialist

Location/Division Tempe, AZ

Direct/Permanent

If interested, please send resumes to Jason@ccsiinc.com

Must have 510k experience in a Medical Device industry.

The position of Regulatory Affairs Specialist will provide technical and administrative regulatory support to ensure timely introduction of new products subject to medical products regulations. Provide regulatory support to marketed products.

Job Functions:

Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
Prepares U.S. FDA submissions (e.g., 510(k), IDE, PMA) as required and per applicable SOPs.
Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
Assists Bard Corporate in updating establishment registrations and device listings as required.
Ensures adequate documentation of Bard Peripheral Vascular’s compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.
Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Bard Peripheral Vascular’s notified body.
Basic Qualifications:

Minimum of 3-4 years RA related experience.
Knowledge of U.S. and/or European and international regulations and standards covering medical devices.
B.S. degree or equivalent with emphasis on Life Sciences.
Professional certifications preferred.
Knowledge and experience 4-6 years with regulatory requirements for medical devices including submission of IDE's, PMA's and 510(k)'s, and CE mark technical files.
Additional Desirable Qualifications Skills and Knowledge:

Professional certifications preferred.
Good oral and written communications skills and ability to work on cross-functional teams.
Working knowledge of statistics and electronic documentation and information systems.
Ability and desire to travel as needed.

Thinking about applying for this position?
Please make sure that you meet the minimum requirements indicated for the job before you apply (see user agreement). If you are qualified, then use either the email link (near top of post) or the application link (near bottom of post) to apply, whichever is provided.