Job Information
Danaher Corporation Regulatory Affairs Manager - EMEA in Little Chalfont, United Kingdom
Be part of something altogether life-changing!
Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40+ countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Forming part of the Biotechnology segment at Danaher, we bring together dedicated technical expertise and talent to develop the next generation of life-changing therapeutics.
The Regulatory Affairs Manager - EMEA for Cytiva is responsible for managing a team of regulatory affairs professionals and ensuring regulatory compliance for Medical Devices placed on the market in EMEA.
This position is part of Medical Regulatory Affairs and will be based on-site. Our vision is, to advance future therapeutics from discovery to delivery.
What you will do:
Responsible for the regulatory compliance of Cytiva products placed on the market as Medical Devices in the EU ensuring compliance with all applicable regulations and ISO standards, primarily; Medical Device Regulations (MDR 2017/745), ISO 13485 and ISO 14971.
People leader who provides management and development of a team of Regulatory Affairs professionals, with in-depth knowledge of regulatory affairs and related disciplines.
Manage/assist in the creation and maintenance of regulatory CE technical documentation for new product introductions and product changes, including oversight of processes for Post Market Surveillance, Risk Management and Clinical Evaluation.
Responsible for Regulatory Affairs activities for EMEA region to enable successful regulatory submissions, registrations, renewals and listings.
Interact with Regulatory Authorities within the EMEA region and Notified Bodies.
Provide support as required for Person Responsible for Regulatory Compliance (PRRC) according to the article 15 MDR 2017/745.
Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
Who you are:
You have a Life Sciences degree or equivalent.
You have regulatory experience in a healthcare / life sciences industry with experience of managing a team.
Working knowledge of Medical Device regulations (EU MDR, MDD, MDCG guidelines), ISO 13485 and ISO 14971.
Good attention to detail.
Have excellent oral and written communication.
The ability to present technical, product and regulatory information to key stakeholders and management within the business.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
Ability to travel required at 25% or less within the EMEA region.
It would be a plus if you also possess previous experience in:
Other global regulatory frameworks or processes.
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com .
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.