Manager REGULATORY AFFAIRS Medical Device MN

Our client is a diversified medical device company engaged in developing, designing, manufacturing and bringing to market SURGICAL devices for the surgical and interventional treatment of disease.  This is an exceptional opportunity for the right individual to bring their skills and expertise in Regulatory Affairs to a new level of recognition with an outstanding company.
  Regulatory Affairs (RA) Manager-Medical Device-Surgical Minneapolis area


Summary


Direct regulatory submission activities to FDA and International markets. Prepare regulatory strategies/plans and worldwide. Negotiate directly with FDA on projects/products.  Participate and provide regulatory  leadership to process/product improvement teams.  Provide regulatory support for market-released products as necessary.  Provide leadership, management, work direction, training, support and project advice to the Regulatory staff including setting of objectives, professional development, and process improvement initiatives.


Responsibilities


• Manage objectives, projects and responsibilities of Regulatory personnel
• Assess regulatory requirements and develop worldwide regulatory strategies obtaining timely regulatory approvals.
• Prepare U.S. and international submissions for new products and for products with significant changes.
• Establish, and maintain good working relationships with regulatory agency personnel.
• Provide support to market-released products by reviewing Engineering Change Orders, labeling, promotional materials, documentation of changes, and maintaining product files to ensure compliance with regulatory requirements


 Requirements


• Four-year Bachelor’s degree,  biological or medical discipline desired. 
• 5-8 years of related medical device experience in a medical industry
• 3-5 years regulatory experience
• Demonstrated proficiency with regulatory planning/strategy, submission planning/preparation . including a working knowledge of both domestic and international device laws and regulations,
• Excellent communication skills including verbal, written and personal computing skills
•  High level of research, analytical, problem solving, strong attention to detail and project management skills
•  Must have the ability to work closely with other personnel/departments in providing strong leadership  with internal regulatory services and in collaborating efforts, particularly with Marketing & Sales, Research and Development, and Quality Assurance. 
• Ability to plan and prioritize effectively, handle multiple projects, and work independently


Leadership and management experience viewed positively!
 
Local candidate considered.  Excellent salary and benefits provided.  Submit your word document resume and salary history in confidence to be considered for this outstanding opportunity.


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