Regulatory/Quality System Principal Advisor

Job Overview:

We are hiring a Regulatory/Quality System Principal Advisor in our Minneapolis, MN office.

This role will be responsible for the initiation, implementation, and management of regulatory strategies, submissions and quality compliance activities that meet global regulatory client requirements.  Key liaison with clients and regulatory bodies leading and coordinating device approval matters.  Develops and implements business development strategies, mentors other staff. Education/Qualifications:

Advanced degree in a scientific or technical field. Professional certification (i.e. RAC) desirable. Experience of at least 12 years with regulatory/quality management responsibility in lieu of the advanced degree will be considered.

 Experience:

Minimum of 15-20 years of experience in medical device companies, managing a multi-disciplined regulatory affairs/quality projects.

 Successful track record and broad understanding of global regulatory affairs and quality requirements. History of cooperative working relationships with the FDA and global regulatory agencies. Strong understanding of clinical trial design and execution, quality systems, and regulatory compliance. Can apply scientific rigor as well as the objective placement of facts before regulatory bodies. Develops and champions an organizational culture that promotes superior performance. Management experience is preferred. Superior oral and written communication skills; must feel comfortable writing, speaking and presenting to a variety of audiences. Effective interpersonal skills. Strong organizational skills and detail-orientation. Demonstrated abilities to communicate cross-functionally throughout organizations. Familiarity with basic computer applications, e.g., Word, PowerPoint.