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International Regulatory Affairs Manager, Medical Device

Location: United States,
Reference ID:

Our client is a unique, global Medtech company with a rich history of success in the areas of Advanced Wound Care, Ostomy, Critical Care, and Infusion with close to 10,000 employees worldwide.  They are in a new growth stage with incredible, disruptive technology that will bring great value in improving patient lives.  Our client is expanding its current portfolio with advanced technology that includes software development, and SaMD.  We are partnering to help bring on an International Regulatory Affairs Manager to oversee RA submissions, RA global strategy, and mentor and lead a team of RA professionals.  This leadership position will ensure regulatory compliance for product categories, change controls, labeling, sales & marketing collateral oversight, and be involved in providing regulatory insight and direction to other business units NPD, NPI, and product lifecycle.  

The Right Talent: 

BS in a relevant degree

6+ Years of RA or Quality experience in the Medtech industry

1+ year of leadership experience with direct reports

Experience interacting with the FDA and governing bodies

Experience with international submissions for LATAM, APAC, EMEA, and EU preferred

Project Management experience leading teams cross-functionally

Understanding of US and EU pathways for regulatory submissions

Ability to travel as needed: 0-30%

Strong communication and problem-solving ability

 

 Remote with some travel

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