Job Description
Job Title: Regulatory Affairs Specialist IDuration: 5 Months (Contract with high possible ext.)
Location: Chaska MN 55318 Job Description:- Plans, coordinates, facilitates, and reports on Industry regulatory programs.
Responsibilities may include: - Administration of the companies complaint management program for compliance to corporate requirements
- Assist in the planning and implementing pre-market registration, reporting and compliance activities in accordance with the business plans.
- Assists in the implementation of global regulatory compliance programs for product corrective action and/or adverse event reporting.
- Assist in the preparation of premarket or other regulatory submissions (510(k), PMA, Technical Dossiers, etc.) for US and other governments.
Educational requirements: - Bachelor's degree in field with 2+ years exp. OR Master's degree in field with 1+ years exp.
- IVD experience strongly desire.