The Regulatory Affairs Specialist for Cytiva is responsible for supporting regulatory compliance of Medical Devices placed on the market in EMEA. This position is part of Medical Regulatory Affairs located in Portsmouth, UK and will be on-site. At Cytiva, our vision is, to advance future therapeutics from discovery to delivery. What you will do:

Compile all aspects of Technical Documentation for product certification under Regulation (EU) 2017/745 for Medical Devices.
Submit Technical Documentation to Notified Bodies for review and approval.
Provision of regulatory information to support product registrations and notifications within EMEA.
Provide support as required for UK Responsible Person with regard to the requirements set out in the UK MDR 2002 relating to medical devices.
Participate in and support activities associated with the Medical Regulatory Affairs team objectives, as directed by line manager.

You have a Life Sciences degree or equivalent.
Proven skills/experience in a healthcare / life sciences industry in a regulatory , quality or technical field.
Working knowledge of Medical Device regulations (EU MDR, 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 clearly and concisely.
Ability to travel required at 10% or less within the EMEA region.

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.