Regulatory Affairs Specialist

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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.

Working at Cytiva means being at the forefront of providing new solutions to transform human health. Our customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies. You will be able to continuously improve yourself and the team by tackling challenges that matter, with colleagues who care for each other, our customers, and their patients. Cytiva has associates across 40+ countries and offers long-term career growth and skill development.

• 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.
• Support RA-related QMS documentation, complaints assessment, vigilance reports and change controls.
• Support medical device Regulatory Intelligence processes and customer requests.
• 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.
• You have at least 2-3 years experience in a healthcare / life sciences industry in a regulatory or technical field.
• Working knowledge of Medical Device regulations (EU MDR, MDCG guidelines, other EMEA), ISO 13485 and ISO 14971.
• Experience with Quality Management System documentation.
• Ability to communicate effectively across all departments and functions.
• Good attention to detail.
• Excellent English 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.

For more information, visit www.danaher.com.

• Not Applicable

• Full-time

• Legal