Medical Device Global Regulatory Lead

What you'll do

• Support from medical device regulatory aspect both centralised and decentralised submissions of Gedeon Richter‘s small molecules and biological  medicinal drug -device combination (DDC) products
• Responsible for coordination of the entire process of compiling technical file and for the compliance of the documentation compiled for the medical device part in DDC products
• Ensure that medical device regulatory obligations for marketing authorisations are met
• Ensure to be the knowledge center for EMA, national European Regulatory Authorities, FDA and other Competent Authorities in case device related questions are raised
• Collaborate with internal and external teams to provide Global Regulatory Advice related to medical device our the medical device part of a DDC
• Participate in the development of RA strategies for new product submissions starting from early stages
• Ensure compliance by coordinating all required RA post-approval activities in close cooperation with medical device vigilance and QA
• Coordinate post-approval support for existing medical devices our medical device related matters
• Support the development and/or subsequent maintenance of IFU 
• Track, interpret and advise on European and national regulations to maximise and protect the effective life of products
• Provide regulatory assessment during due diligences of potential in-license projects and support business development decisions in medical device realted productgs

What You’ll Bring

• MSc degree in engineering and/or life sciences ideally with a PhD
• Substantial European MDR experience – including practical experience with European regulatory procedures and interactions with notified bodies /authorities
• Experience in medical device and combinations product related US FDA  requirements is an advantage
• Years of experience in a RA/QA position at a medical device company or at a pharmaceutical company with DDC products in the portfolio would be an advantage
• Years of experience at a Notified Body in the field of medical devices as a member of a personnell involved in conformity assessment activities is an advantage
• Project management skills
• Analytical skills to interpret available data and make critical regulatory decisions
• Ability to organise and manage diverse activities in a multi-disciplinary environment, communicating with global and local groups
• Strong inter-personal skills for efficient cross-functional communication
• Efficiency in problem solving as applied to regulatory issues
• Excellent verbal and written communication and presentation skills in English

We offer

You can work in a team of helpful colleagues, where we value supportive collaboration and thinking together. In addition, we offer
•    Challenging, responsible professional work
•    Opportunity for continuous development
•    Long-term employment in an innovative and secure workplace
•    Training and development opportunities
•    Medical services and life insurance
•    Various sport and health opportunities
•    Extensive benefits package