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Regulatory Manager

Des Plaines, IL
JOB TITLE: Manager, Regulatory Affairs
Chicago, IL

: The Regulatory Affairs Manager provides direction and leadership in the development and implementation of regulatory strategies in the global commercialization of company products.
The position will support new product development initiatives as well as sustaining efforts of existing medical device product lines. Responsible for defining the regulatory requirements for project teams, prepare and submit product applications to the regulatory agencies including US FDA and European notified bodies. This is a people management and individual contributor role that will be critical in achieving business goals through others, and in the development of professional staff members.

  • Lead team of Regulatory Affairs professionals in driving market access of the medical device product portfolio. Including preparation of regulatory filings in both US and international markets.
  • Develop and execute regulatory strategies for new product introductions, and changes to design, labelling, and manufacturing processes.
  • Serve as liaison and build rapport between the company and regulatory agencies
  • Ensure regulatory compliance in the review of advertising and promotional materials.
  • Provide work direction and development plans for direct reports.
  • Collaborate with management in establishing departmental goals, strategies and procedures in support of business objectives.
  • Provide training and education on Regulatory topics both internally and externally.
  • Proactively assess, communicate and plan for new and changing regulatory requirement
  • Bachelor’s Degree.
  • 4+ years’ experience with increasing responsibility in regulatory affairs, preferably in medical devices. Demonstrated history of successful regulatory experience to support business objectives.
  • Developed knowledge and demonstrated expertise with US and EU MDR regulations.
  • Effective relationship management, ability to network, support and influence across functional groups. Proof of strong written and verbal communication skills, especially when dealing with governmental agencies.
  • Ability to explain and resolve differences in regulations.

  • Degree in a scientific, engineering or related discipline.
  • Advanced degree and/or professional certification in regulatory affairs.
  • Demonstrated leadership in prior role
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