Are you interested in a Regulatory opportunity within a growing industry? Our client is in need of a Regulatory Affairs Specialist to join their expanding Biomedical Manufacturing team! This opportunity is located in the SW metro area and provides exceptional growth potential! 
 

Responsibilities of the Regulatory Affairs Specialist: 

• 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.

Requirements of the Regulatory Affairs Specialist: 

• Bachelors degree in field with 2+ years experience
• OR Masters degree in field with 1+ years experience 
• IVD experience strongly preferred