In order to ensure compliance with global regulations, our client, a global medical device company, has tasked us with identifying and recruiting a highly qualified, experienced and motivated individual to take the role of Director Regulatory Affairs.
The successful candidate will manage his own team of professionals and plan, guide and coordinate regulatory affairs activities within the company.
The successful candidate can be based in Esch-sur-Alzette, Differdange, Dudelange, Ettelbruck, Diekirch, Wiltz, Echternach, Rumelange, Grevenmacher, Remich or anywhere in Luxembourg.

The candidates must have derma/wound care experience and/or ideally semi-solid formulation experience.

Key responsibilities:

• Maintain professional relationships with key targeted organizations and individuals
• Develops and implements an integrated medical affairs plan and budget that supports development, marketing and sales strategies and projects for the Company portfolio
• Manage all the product registration submissions and other regulatory documents and work in collaboration with the quality department as needed.
• Ensure regulatory compliance of all marketing materials
• Provide expertise in support of developing content for medical communications and education
• Develop and maintain strategies and data management processes to ensure clinical and health economic excellence of company products
• Participate in executive management meetings as required

Candidate profile:

• At least 7 years of experience with Regulatory Affairs within the Health care sector
• Deep knowledge of the applicable standards and laws (EU MDR, ICH, GMP, GDP, c-GMP, CBER regulations)
• Educated to degree level in Pharmacy or other healthcare-related discipline combined with relevant knowledge in biologics and semi-solid formulations through experience
• Proficiency in English, German, French or Dutch would be considered as a plus
• Strong leader with the drive and determination to inspire achievement in their team
• Outstanding communication, presentation and negotiation skills