Contract: Regulatory Affairs Specialist I / US

The client are currently recruiting a Regulatory Affairs Specialist I to work on a 5-month contract.

The Regulatory Affairs Specialist plans, coordinates, facilitates, and reports on Company regulatory programs.

RESPONSIBILITIES:

• Administration of the company's 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.

QUALIFICATIONS:

• Bachelors degree in field with 2+ years exp. OR
• Masters degree in field with 1+ years exp.
• IVD experience strongly desired.