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About our client
Our client is a leading producer of medical device products with approximately 4,000 employees globally. The company has exceeded all growth expectations over the past few years and has demonstrated a stable history, recently celebrating their 50th anniversary! This is a great situation for a candidate that is pursuing a challenging and visible opportunity with a world-class employer.
Position	Location
Regulatory Affairs Supervisor	Minneapolis, Minnesota
Salary
Highly competitive package, commensurate with experience
Responsibilities
1) Supervise compliance with FDA device and drug registration’s listing and pre-market requirements for company’s marketing products in the US 2) Maintain contact with appropriate regulatory agency departments 3) Supervise compliance with FDA requirements regarding export of products from the US 4) Oversee compliance with departmental documentation procedures 5) Handle the compliance database and controlled documents with maintaining applicable files, databases and records 6) Update and follow company CAPA policies and procedures 7) Supervise and oversee the maintenance of CAPA program and policies 8) Train company personnel in complaint handling as well as CAPA policies and procedures 9) Prepare regulatory submission cover letters 10) Arrange teleconferences and meetings with regulatory agencies and produce comprehensive meeting minutes 11) Develop and maintain databases to support FDA activities and regulations 12) Supervise and monitor all FDA recalls, field corrections and related product matters 13) Monitor (closely) daily FDA information release and other identified sources 14) Maintain current understanding of FDA’s position on all aspects of medical device development and market introduction requirements 15) Remain current on the analysis and summary of new FDA guidance and other regulatory obligations of the company 16) Supervise and coordinate regulatory affairs to ensure availability of documents and company information in the preparation and support of the submissions of 510ks (510k memos, file updates, etc.) as the company enters products into various classifications 17) Interact with various development groups in the company to ensure compliance with FDA regulations 18) Interact closely with FDA and other regulatory authorities, including EU health agencies and Health Canada
Requirements
1) BS in a scientific field 2) 3 – 5 years of experience in US, Canadian and EU product development regulatory affairs (medical devices) 3) Experience in clinical and preclinical medical device 4) Expertise in preparation and submission of regulatory affairs’ health authority submissions 5) Experience in handling team meetings 6) Basic knowledge of US, Canadian and European regulatory standards 7) Excellent coaching and interpersonal relationship skills 8) Excellent project management skills 9) Self-starter, initiator and team player 10) Ability to adapt to changing projects and deadlines 11) Well-organized, flexible and detail oriented individual 12) Good communication (written and verbal) skills 13) Willingness to travel internationally (occasionally)