Regulatory Affairs Assoc.

REGULATORY

Headquartered in Chaska, Minnesota, Lifecore Biomedical is a medical device company dedicated to the design and manufacture of innovative products that enhance the quality of life for people worldwide.

 

Sr. Regulatory Specialist

 

In this position, you will proactively manage the creation and update of regulatory documents such as worldwide submissions, registrations, design dossiers, technical files, drug and device master files to ensure compliance with FDA and international drug and device regulations.

 

Qualifications include B.A./B.S. degree (Engineering, Sciences, or Chemistry preferred). 5+ years experience in medical device/pharmaceutical industry. Experience preparing and filing FDA (510(k), PMA, and IDE) and international submissions for new products and product changes. Working knowledge of FDA device and drug regulations, GMP’s, ISO and MDD requirements. International regulatory experience preferred.

 

Lifecore offers an attractive salary and benefits package, as well as generous paid time off, flexible work week and matching 401(k). Please send resume to:

Lifecore Biomedical

3515 Lyman Boulevard

Chaska, MN 55318

Fax: (952) 368-3411

klweiss@lifecore.com

www.lifecore.com

Equal Opportunity Employer