8460 Regulatory Affairs Manager
Barrington, IL

Our client provides transformational medical technologies that are shaping a new age of patient care. Their expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease, so their patients can live their lives to the fullest.

In this role, the Regulatory Affairs Manager will manage a team of Regulatory Affairs experts to ensure company establishes best practice standards in the development of new products.

Responsibilities include:

• Lead development and maintenance of product approval/clearance/licensing documentation and notifications as required by regulatory agencies. This documentation includes, but is not limited to:
• FDA PMAs or 510ks
• Notified Body Technical Files and updated notifications
• Documentation, applications and notifications required by specific country
• Lead RA efforts as member of cross-functional teams in support of Engineering, Service and Manufacturing projects to ensure regulatory activities are completed (e.g. labeling reviews, 510k decision tree, etc)
• Lead direct report RA employees within the team, mentoring, coaching and teaching the team on RA activities (specify approx # of direct reports)
• Manage the recruitment, development and training plans of each direct report
• Ensure Regulatory reporting/documentation is completed and updated as required. Includes but is not limited to: Site Registrations, Product Licensing and Product Listings.
  

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