Global Regulatory Lead

Join the professional team of the 120-year-old Gedeon Richter Plc., a leading pharmaceutical company in Hungary and the region!

New molecules, new medicines, new processes, and new technologies - Richter invites innovative minds to exploit their full capacities. With our research and development base with 1000 professionals, we have one of the most significant innovation centres not only in Hungary but in the entire Central and Eastern European region. In addition to applied scientific work, we also support individual research fields and topics, as well as publishing activities and participation in scientific life.

Gedeon Richter is looking for a committed and experienced professional for the position

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 or 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 products

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

The Richter community is looking forward to your application.