Regulatory Affairs Manager

(Job Id W314237)
Posted on 3/29/2010
Location:

New Haven, CT


Job Type:

Full Time


Salary: $110000.00 to $125000.00/year
Degree: Bachelor
Job Description
Our client, a Successful Fortune 500 Medical Device organization has a new opening for a Senior Level, Manager of Regulatory Affairs.

The Regulatory Affairs Manager coordinates, compiles, and submits product applications to regulatory agencies.

MINIMUM REQUIREMENTS:

Education required: Bachelors degree required (BS in Physical Sciences preferred). Masters degree in business preferred.

Experience: Minimum of seven years Regulatory Affairs experience required (device registration experience preferred). Minimum four years experience managing a professional staff required.

Reporting directly to the Senior Director of Regulatory.

The Regulatory Affairs Manager is responsible for worldwide product approval submission activities for Class II and III Medical Devices. This person will plan and implement policies, procedures, practices, and strategies for the Regulatory Affairs. Collaborate with R&D, Clinical, and Quality functions to execute regulatory strategy from product inception to product launch.

Daily/Weekly Duties include:

Develop, document, and implement regulatory strategy for new technologies and product modifications.
Prepare IDE, 510(k), PMA, CE Mark, and other related regulatory filings.
Ensure the timely and accurate filing of regulatory documentation.
Interface with FDA, TUV, and other regulatory agencies regarding regulatory submission strategy and approval reviews.
Collaborate with Clinical to develop clinical trial plans and reports.
Collaborate with R&D to determine and execute pre-clinical test plans in support of regulatory submissions.
Establish and maintain a professional and credible image with FDA, TUV, and other regulatory agencies.
Provide regulatory affairs support to the document control/change request system.
Attend review board meetings
Maintain superior knowledge of competitive technologies in addition to medical and technical developments related to the companys products.