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Job Details

Regulatory Affairs Manager

Company: EPM Scientific
Location: New York
Reference: ts12121
Closing Date: 27 Jan 17
Type: Permanent
Salary (£): 100,000+
Benefits: Bonus + Excellent Health Benefits

Job Summary:

Regulatory Affairs Manager Needed for Top Medical Devices Company Globally!Regulatory Affairs | Manager$90,000 - $140,000 + Bonus + Excellent BenefitsNew York, New York


Regulatory Affairs Manager Needed for Top Medical Devices Company Globally!

  • Regulatory Affairs | Manager

  • $90,000 - $140,000 + Bonus + Excellent Benefits

  • New York, New York

This well established and well respected Medical Devices Company is seeking a Regulatory Affairs Manager to help improve, expand, and lead their department going forward. With big plans for expansion and growth for the New Year, there is a great deal of career progression involved with this position, as it is an expansion role. The Regulatory Affairs Manager will have a chance to lead and grow his/her team moving forward, liaise with regulatory authorities for advice and guidance and provide support and advice on regulatory issues to other areas of business. 

The Regulatory Affairs Manager will have the following responsibilities:

  • Responsibility for developing regulatory plans with high level of complexity

  • Plan and prepare documentation for international and domestic product registrations for new and modified products

  • Provides regulatory support for diagnostic product development and commercial diagnostic products

  • Compiles and publishes all material required for submissions

  • Maintain approvals/licenses/authorizations for existing marketing authorizations

The Ideal Candidate will have the following Skills Set:

  • BS/BA in any biological Science

  • 8+ years experience in Regulatory Affairs US and International

  • 5+ experience in an IVD or Medical Device Manufacturing Environment

  • Strong knowledge of Quality Systems and federal and international Regulations

  • Proficient with Microsoft Office


Apply for this job: Regulatory Affairs Manager

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

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