International Regulatory Affairs Director - Take Decisions

A rapidly growing medical device/pharma company is looking for an International Regulatory Affairs Director to be the most senior person in the Regulatory department. They have a niche product portfolio and ambitious plans to bring them to the patients all over the world and you can put your stamp on the Regulatory Affairs department.

You will lead a small RA team and will be responsible to plan and implement some important projects such as getting FDA approval so you can use your regulatory expertise and make more decisions by yourself. Their product is registered as a medical device in EU but it will be registered as a biologic in the US so it will be a challenging situation.

Responsibilities:

• Point of contact for notified bodies and other legislative authorities
• Responsible for all registrations in EU and US
• Develop and implement company wide regulatory strategies
• Responsible for regulatory compliance
• Manage the regulatory team

Requirements:

• Master Degree or PhD in life sciences or related
• Several years of experience in Regulatory Affairs for the pharmaceutical and the medical device industry, the combination of pharma and medical devices is required
• Experience with the FDA approval process for biologic, topical or semi-solid drugs
• Experience with people management is an advantage
• Strong knowledge of international legislation (EU MDR, FDA approval,…)
• Fluent level of English, Dutch, French or German is an advantage

Benefits:

• Market rate basic salary
• Attractive extra benefit package
• Flexibility to work home based
• Exciting growing working environment with constant learning and development opportunities

If this job appeals to you please apply here or on the NonStop Consulting website or send it to me, Annelies De Baere, on my Linkedin. If you are not available but you know someone that would be interested, please forward this to them and help the people in your network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. Please visit our website for a full list of the niche markets we cover.