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Regulatory Affairs Manager

Regulatory Affairs Manager

Job Title: Regulatory Affairs Manager
Contract Type: Permanent
Location: Los Angeles, California
Industry:
Salary: Negotiable
Start Date: asap
Reference: HQ00051539
Contact Name: Pavlina Bullaj
Contact Email: p.bullaj@sciproglobal.com
Job Published: February 06, 2017 13:50

Job Description

Regulatory Affairs Manager

Industry: Medical Device

Location: Los Angeles

One of my key clients is currently looking for a Manager Regulatory Affairs based in their head office in LA.

As the Regulatory Affairs Manager, you will play a key role acting as the regulatory affairs subject matter expert for all applicable medical devices (class I, II & III). You will be responsible for identify, assessing and communicating the regulatory development and submission strategies, regulatory risks, interface with relevant regulatory authorities and review device aspects of all regulatory submissions.

Previous experience in developing strategies for regulatory approval (USA & OUS) for clinical and preclinical trials is ideal as you will be responsible for providing regulatory guidance to clinical Affairs, Quality Systems and Manufacturing & Development. As a result you will be responsible for preparing submissions, obtain and maintain their approval while ensuring all activities are carried out in compliance with all applicable laws and regulations.

The client is looking for someone with a strong technical & analytical background who is not scared to be hands on and therefore be able to exercise independent judgment in determining appropriate actions.

Must Have

  • Minimum 5 years of Regulatory Affairs Experience with Class I, II & III medical Devices
  • National & International Regulatory affairs Experience working with the FDA, EU & Health Canada
  • Managed, prepared and submitted original IDEs, PMAs, HDEs, 510(k)s, documentation for CE Mark including technical files, and all applicable supplements and/or amendments
  • Documented experience in producing related regulatory submissions (annual reports, change notifications, etc) and 510(K) letters to file to facilitate maintenance of approvals

If you think you have the appropriate experience and would be interested to hear more, please apply below or alternativly send me an email with a good time to call and your contact details.