Regulatory/Quality System Principal Advisor at Covance in Minneapolis, MN

Job Overview:

We are hiring a Regulatory/Quality System Principal Advisor in the Minneapolis, MN office or remote based.

The Principal Advisor (PA) is an experienced leader in medical device and/or diagnostic regulation and is expected to leverage that experience to aid Medical Device & Diagnostic (MDD) to grow its portfolio of innovative and profitable business. The PA will oversee the design of effective and differentiated strategies for regulatory evidence development and operational delivery with clients and internal experts and will actively participate in RFI/RFP and bid defense strategy and execution activities. The PA is responsible for the initiation, implementation, and management of regulatory strategies, submissions and quality compliance activities that meet global regulatory client requirements. The PA serves as a key liaison with clients and regulatory bodies leading and coordinating device approval matters. The PA is expected to establish and grow client relationships, be seen as an industry leader, engage as a leader and subject matter expert (SME) in relevant process improvement and change management activities, develop and conduct internal training programs, and mentor junior 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 twelve 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. Apply scientific rigor as well as the objective placement of facts before regulatory bodies.