Job Announcement: * URGENT NEED * Medical Regulatory Affairs * Director and Manager

Job Number: CCW4011         

Job Title: Global Regulatory Affairs Director and Manager

Location:  Easton, PA

Industry:  Medical

Type:  Full Time

PLEASE NOTE: Your resume will not be properly formatted if you respond to this posting via monster board or another job board.  To properly respond, you should format your resume in MS Word or Corel WordPerfect and send it to Christie@jobquestsite.com as an attachment.  Please visit our website at http://www.jobquestsite.com/ to view other career opportunities.

PLEASE DO NOT RESPOND TO THIS POSTING IF YOUR BACKGROUND DOES NOT MATCH THE REQUIREMENTS DETAILED BELOW. 

OVERVIEW

­Small/Medium Reputable Medical Company (confidential) has urgent need for 2 Regulatory Experts!

Pharma/Med Device/Diagnostic Experience Applicable

Ensure compliance with the U.S.A FDA Code of Federal Regulations, the European in Vitro Diagnostic Directives, EN 13485 and other Quality Standards as appropriate. This includes, but is not limited to, the design input, review, out-put and verification, validation, transfer and change control. Provide updates as needed to supervisor regarding regulatory status and requirements, both U.S. and European, of Company products. This includes the implementation of CE marking to products in accordance with IVDD 98/79/EEC. Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CBER and TUV etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.

QUALIFACTIONS/SKILLS

Global Regulatory Affairs Director 12-15 years experience, PhD required

Global Regulatory Affairs Manager 8-10 years, M.S. required, PhD preferred

Focus on US (primarily), Latin America, and Europe

Excellent verbal and written communications skills A MUST!

Supervisory Experience A MUST

Collaborator Instinct NECESSARY!

COMPENSATION/BENEFITS

Director: up to $175K, bonus 20%, equity, full benefits

Manager: up to $100K, bonus 7%, full benefits

Terrific Corporate Culture

Leading Product Innovator

To apply: Please apply via email to: Christie Whisnant   christie@jobquestsite.com

CHRISTIE WHISNANT * MRI NETWORK RECRUITER* christie@jobquestsite.com * 843-477-8800 x315 

My office is part of Management Recruiters International, Inc. the largest and most successful search and recruitment firm in the world.  Located in Surfside Beach, SC, we use our immense resources to successfully recruit for major companies located nationally and internationally.  For more information about our company, I invite you to visit our website at http://www.jobquestsite.com/.  I specifically work with Medical, Pharmaceutical, Biotech, Nutraceutical, and Cosmeceutical recruiting for various positions in Research, Development, Clinical and Medical Affairs, to name a few.  I am a very professional and reputable resource for professionals interested in achieveing career goals.  I operate in a confidential nature and do not disclose information without a candidate's prior consent.