Judge Technical Staffing seeks a Director Regulatory Affairs for a leading biotechnology client in Bethlehem PA.

****Ability to travel  up to 25%. Additional travel may be required based on business need.****

Successful candidate is responsible for strategic planning of the RA function supporting the development, implementation and management of global regulatory strategies. Responsible for licensing of new products as well as life cycle management of existing products, including all International/US submissions (510(k)s/PMAs/IDEs and Dossiers.

Must Have:

*510K submission experience

*One on one FDA interface experience

*10-15 yrs regulatory exp and advanced degree

Requirements:

Bachelors/Undergraduate Degree in quality or science (chemistry, biology, or medical technology). MBA, preferred.

Ten (10) years progressively responsible related experience in a drug manufacturing, medical device, or biologics industry in a Regulatory Affairs or Quality Assurance position.

Minimum 5 years supervisory experience, desired.

Demonstrated experience in development and management of regulatory submissions and documentation including but not limited to US FDA (21CFR 820 QSR, 21CFR 600 and 21 CFR 211) ISO9000, ISO 13485, EN 13485, MDD, IVDD,, facility registrations, IND, 510k, BLA.

Demonstrated experience with internal and external audit processes.

Demonstrated understanding of Regulatory Affairs, Quality Assurance audit functions and Quality Control principles. Qualified Auditor, EU is preferable but not required.

Please contact:

Deirdre Middleton

1-888-228-7162 x1581

610-667-7700 x1581

dmiddleton@judge.com