Judge Technical Staffing seeks a Regulatory Affairs Manager for a client in Bethlehem, PA.

****Approximately 30% US travel***

Successful candidate must have:

*Hands on experience with the development and management of 510K regulatory submissions and documentation.

*Experienced interfacing directly with the FDA.

*Five to Seven years progressively responsible related experience in a drug manufacturing, medical device, or biologics industry in a Regulatory Affairs or Quality Assurance position.

*Minimum 2 years supervisory experience, desired.

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

*Compile device master records, technical files, design dossiers, FDA and European submission documents, and/or any other related documents/reports, ensuring timely submissions to CBER and TUV etc., to meet Company product(s) and regulatory requirements, and compliance to all approved licenses.

*To review Change Control requests, deviation requests, quality system reports for adequacy and compliance with company and regulatory requirements. Responsibility for Biologic Product Deviation Reports in compliance with the Code of Federal regulations.                           

*To participate in the investigation of failures and participate in continuous improvement initiatives.         

Please contact:

Deirdre Middleton

1-888-228-7162 x1581

610-667-7700 x1581

dmiddleton@judge.com