Director, Regulatory Affairs & Quality Assurance

Job Locations US-WI-Madison
Req No.
2017-2005
Category
Quality Assurance & Regulatory Affairs
Type
Regular Full-Time

Summary of Major Responsibilities

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. 

Essential Duties and Responsibilities

  • Identify and develop new regulatory policies, processes and SOPs.
  • Provides current regulatory intelligence and formulates regulatory strategies.
  • Oversees implementation of regulatory strategy and activities needed to secure approval of new products, including in vitro diagnostics and medical devices.
  • Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
  • Assures QMS compliance to the QSR, 21 CFR 820, ISO 13485, and any other applicable QMS regulation.
  • Oversees coordination, preparation and timely submission of regulatory documents to secure and maintain market access.
  • Provides regulatory advice to other functional areas.
  • Serves as a principal interface with reviewers and auditors from FDA and other health authorities (e.g. Notified Bodies, National/Regional competent authorities, etc.).
  • Identifies perceived gaps in product development plans that may pose regulatory issues.
  • Develops and maintains relationships with external vendors and regulatory authorities to improve effectiveness in regulatory strategy execution.
  • Coordinates preparation of responses to queries from regulatory authorities and auditors.
  • Coordinates activities pertaining to meetings and conferences with regulatory authorities.
  • Oversees regulatory authority inspections and provides input for follow-up to inspections and audits to minimize potential for findings of noncompliance.
  • Oversees activities related to post-market surveillance, including complaint handling.
  • Oversees activities related to product recall and recall communication process.
  • Assures medical device reports (MDR) are reported to regulatory agencies and internal stakeholders.
  • Manage processes involved with maintaining annual licenses, registrations, listings and patent information.
  • Ensures compliance with product post-marketing approval requirements.
  • Reviews and approves advertising and promotional items to ensure regulatory compliance.
  • Mentors department personnel and updates appropriate departments on the current regulatory environment.
  • Leads employees, consultants/contractors in Regulatory Affairs and Quality Assurance.
  • Optimizes employee performance by developing employees and promoting career growth.
  • Develops and implements operating guidelines and common work practices/strategies within the team.

Qualifications

Mandatory Skills

  • Demonstrated ability to interpret and stay current with FDA, EU and other regulatory agency regulations and guidelines.
  • Experience with eCTD requirements and electronic submissions.
  • Demonstrated knowledge of regulatory aspects of Software development, Risk Management, Manufacturing and Controls, and quality assurance.
  • International experience is desired.
  • Understands the principles and requirements of promotion, advertising and labeling.
  • Demonstrated management expertise, including leadership and development of employees.
  • Ability to work effectively across teams, functions and with outside partners.
  • Excellent oral and written communication skills.
  • Excellent organizational skills and attention to detail.

Preferred Qualifications (optional)

 

  • Certification (such as RAC from the Regulatory Affairs Professionals Society).
  • Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. 
  • M.S. in a technical area or M.B.A. is preferred. 
  • A Ph.D. in a technical area or law. 

Education and Experience

  • Bachelor's degree (or equivalent).
  • 10+ years of experience in a regulated industry.
  • 8+ years of experience regulatory affairs experience in the IVD/Medical Device industry.

Physical Requirements

  • Ability to use computers daily in an interactive manner for extended periods of time.
  • Ability to sit for an extended period.
  • Ability to stand for extended periods of time.
  • Ability to constantly move about to coordinate work.
  • Ability to frequently and accurately communicate with employees, customers, etc. face-to-face, via the telephone or by email.
  • Ability to lift and move up to 40 pounds on an occasional basis.

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.

 

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