Regulatory Affairs Specialist

Danaher

  • Portsmouth
  • Permanent
  • Full-time
  • 6 days ago
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 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.
  • Support RA related QMS documentation, Complaints Assessment, Vigilance Reports and Change Controls.
  • Support medical device Regulatory Intelligence process 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.
Who you are:
  • 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.
  • Have excellent English oral and written communication.
  • The ability to present technical, product and regulatory information clearly and concisely.
Travel, Motor Vehicle Record & Physical/Environment Requirements:
  • Ability to travel required at 10% or less within the EMEA region.
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 .

Danaher