Vice President of Regulatory Affairs

QualificationsUS CitizenTechnical Graduate or Master's of Business Administration preferred8-10 years relevant experienceMedical devices and/or pharmaceuticals cGMP, ISO13485 and MDD compliance exposurePreparing regulatory filings in a timely manner including NDA, ANDA, ANADA, and 510(k).Foreign language a plus

 

Job Responsibilities

1.  Manage the regulatory functions of corporate operations in Buffalo, New York and Bethlehem, Pennsylvania.

2.  Insure compliance with cGMP, ISO 13485:2003 and other FDA & international guidelines (such as CE Marking, Health Canada, Japanese PAL)

3.  Register the Buffalo facility for ISO 9001 by June 2007

4.  Supervise the Health, Safety and Environmental function

5.  Insure that appropriate programs are in place to effectively validate suppliers

6.  Rapidly register products (pharmaceuticals and devices) in world markets

7.  Optimize in-process QC testing in the Bethlehem facility

8.  Assist in the development of analytical methods for production and quality control

9.  Responsible for Clinical supervision of product tests/trials and FDA compliance, where applicable

10.  As required, work with the commercial department to communicate with and assist customers on product information or regulatory issues

11.  Such other duties that the CEO or Board may assign

Direct Supervision of:

1.  Registration Analysts

2.  Regulatory Manager - Europe

3.  Quality Control Manager

4.  Quality Control Engineer

5.  Quality Control Analysts

 

Reporting Relationship:

 

  Chairman & Chief Executive Officer

 

Compensation

1.  $104,000

2.  Stock Options

3.  Gross Profit Bonus

4.  Tuition Reimbursement Program Available

5.  Relocation stipend, if necessary