Director, Global Regulatory Affairs

Job Location: 
Libertyville, IL

Ready for a new exciting career opportunity, and to join a committed team with an employee and patient focus? If you have what it takes, you could be the person our client is seeking to fill their Director, Global Regulatory Affairs position. Responsible for leadership of Regulatory Affairs activities for the client.  Primary responsibilities include overall strategic leadership and development of a high-performing Regulatory Affairs team and driving regulatory strategy to best achieve business objectives. Reports directly to the VP level, and the position contributes to the business through regulatory strategies, risk assessments and successful regulatory submissions.  Directs functional activities designed to achieve and maintain global clearance/approval/registration of company products.  Represents company in pivotal interactions/negotiations with regulatory agencies and notified bodies.  Plays an active role in external efforts to influence standards and regulations of strategic importance.

 

Job Responsibilities:

Leads and coordinates the Regulatory Affairs department and related activities

Provides global oversight to medical device regulatory activities

Ensures compliance with all relevant regulations and guidelines

Actively engages with cross-functional partners to ensure alignment of regulatory strategies with business objectives

Partners with Clinical Affairs, Marketing, and Research and Development to develop the most effective strategies to achieve successful submissions and achieve business goals

Communicates potential risks and mitigations associated with regulatory strategies to stakeholders.

Provides leadership to the Global Regulatory Affairs team of managers and individual contributors

Fosters and prioritizes employee career development

Coaches Regulatory Affairs team in the preparation of submissions (i.e. 510k, CE Marking applications, technical documentation, global product registrations, etc.) to obtain global regulatory approvals and maintain existing regulatory approvals through letter to file, renewals, change notifications, etc.

 

Experience and Skill Sets:

Number of Overall Years Necessary: 8-12

Minimum ten years of directly related experience in increasingly responsible positions in the IVD/medical device field

Five or more years of management experience

Expertise in 510(k), Design Dossier, Technical Files, Medical Device Regulation (MDR), and/or International Regulatory support

Bachelor’s degree required preferably in a scientific, technical discipline or project management. 

Advanced degree preferred 

Experience should include demonstrated success in setting regulatory strategy and preparing and filing regulatory medical device submissions (both US and international), as well as negotiating favorable regulatory strategies and timely approvals

 

Apply Now!  Send resumes to tim@pointonerecruiting.com

Recruiter Name: 
Tim Borop
Recruiter Phone: 
(262) 886-8000 ext. 218
Category: 
Manufacturing & Engineering

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