Quality and Regulatory Manager

A leading manufacturer and distributor of medical products is seeking a Quality Assurance and Regulatory Manager with experience in sterile and non-sterile disposable products.The position has responsibility for the domestic QA/RA function and international supplier management.  This is a working manager position with no direct reports.

 

Responsibilities Include:

 

1.  Release sterile and non-sterile products to distribution.

2.  Assure compliance to FDA regulations.

3.  Assure compliance to Health Canada and European Medical Device Directives.

4.  Maintain ISO compliance.

Interface with customers and suppliers on quality, complaints and CAPA.

 

Requirements for this position are:

o  BS degree

o  5+ years medical device experience with non-sterile and sterile disposable.

o  Excellent written and verbal communication skills.

o  5+ years experience with ISO and European Medical Device Directive

 

With corporate headquarters on Long Island, NY - We offer a fast paced team environment where the right individual will assume responsibility for FDA and ISO compliance.  You'll enjoy a competitive salary, comprehensive benefits and solid opportunities for growth.

 

Please send cover letter, resume and salary requirements.