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Exact Sciences is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to age, color, creed, disability, gender identity, national origin, protected veteran status, race, religion, sex, sexual orientation, and any other status protected by applicable local, state or federal law. The Company's affirmative action program is available to any applicant or employee for inspection upon request.

If you need any assistance seeking a job opportunity at Exact Sciences, or if you may require a reasonable accommodation with the application process, please call our Recruitment Coordinator at 608-535-8841 or email jobs@exactsciences.com.
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Job Locations US-WI-Madison
The Regulatory Affairs Specialist writes, files, and obtains approvals for domestic and international regulatory submissions. The Regulatory Affairs Specialist defines the regulatory strategy for assigned projects, including new product development, product changes, and manufacturing improvement initiatives. Assist in creating, developing, and implementing global regulatory affairs procedures and educating others on global regulatory expectations and requirements.
Req No.
2017-2016
Category
Quality Assurance & Regulatory Affairs
Job Locations US-WI-Madison
Reporting to the Vice President of Clinical and Regulatory, the Director of Regulatory Affairs & Quality Assurance is responsible for leading the activities of the Regulatory Affairs and Quality Assurance. This role will lead the strategy and the preparation, review and submission of documents to FDA and other national authorities and oversight of the Quality Management System (QMS), including post-market surveillance, document control and internal auditing. The Director, Regulatory Affairs & Quality Assurance is also the named Management Representative for the QMS. This role must be able to combine knowledge of scientific, regulatory and business issues to assure that products are developed, manufactured, and distributed according to all national, regional, and local laws and regulation pertinent to the manufacture and distribution of medical devices and/or IVDs. The Director, Regulatory Affairs & Quality Assurance will develop, mentor, and supervise regulatory and quality professionals. 
Req No.
2017-2005
Category
Quality Assurance & Regulatory Affairs

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