Retour aux offres d'emplois

REGULATORY AFFAIRS DIRECTOR EMEA / LATAM – F/H

Présentation société

HTI has a solid reputation as a leading executive and middle-management search firm specialised in placing executives and experts in the life sciences sector.

Act as the Primary PRRC for Regulatory for the EMEA and LATAM regions: 
• Lead the Regulatory Affairs Registrations team for approvals and product registrations of all medical devices; 
• Planning and executing all aspects of Regulatory Affairs and acts as the company’s regulatory representative; 
• Develops, approves, and implements corporate regulatory strategies; 
• Lead a team that is responsible for preparing/ reviewing international submissions / technical files / product registrations to successfully obtain commercial distribution of company products. 
• Provide guidance, direction and training in regulations, agency guidelines, and internal/corporate policies to ensure compliance and accuracy are achieved. 
This pivotal position requires exemplary leadership skills, regulatory expertise, and a proven track record in the medical device industry. Serving as the regulatory subject-matter expert, the Director defines, deploys, and leads regulatory, clinical, and compliance tactics. 

Descriptif du profil

• Bachelor’s degree in life sciences; M.S. or Ph.D. a plus.
• Minimum of 8-10 years of experience in regulatory affairs within the medical device industry, with at least 5 years of experience in a leadership role.
• In-depth knowledge of regulatory requirements and standards applicable to medical devices in the EMEA and LATAM regions.
• Proven track record of successfully leading

Postuler

Selina Iwangou-Hammer
shammer@hti-bioquest.com