Global Regulatory Affairs Manager

Description:

This is a company-critical role and your past experiences in Medical Device Regulatory Affairs will be key to help this manager and the global project teams to navigate challenging market-access or remediation projects in multiple countries and regions of the world.

You will be responsible for enabling and navigating product launches in various markets globally, with a key focus in Asia-Pacific region and international markets. Furthermore, you will be responsible for influencing internal teams across different functions to help them understand what the authorities in the APAC typically expect, what are the new regulations, introduce new processes, and assist the HQ with more efficient Regulatory Affairs processes.

In this role you will report directly to the Global Head for Regulatory Affairs at the global headquarters in Asia.

🔸 Your responsibilities:

As the Global Regulatory Affairs Manager you will:

• Keep yourself and your colleagues up-to-date with latest regulatory developments in key global markets (Asia-Pacific, North America, and the EU)
• Identify, review, advise and present plan of action to internal teams globally of the latest regulatory changes in the market and their wider impact on market access, product compliance
• Key point-of-contact for the company’s internal database of regulatory information
• Show leadership by guiding other members of the RA team on different processes in different regions
• Participate (and sometimes negotiate) in governmental and external agency audits and take pre-audit and post-audit actions
• Create internal and external reports for the global headquarters.

🔹 Your qualifications:

For this Global Regulatory Affairs Manager, you will bring:

• At least 12 years’ experience in Regulatory Affairs with a Medical Devices Manufacturer
• Experience within the medical device industry is required
• Fluent written & spoken in English
• Eligible to live and work in the European Union, UK, Switzerland, or EEA