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Regulatory Specialist

2 months ago

West Yorkshire, United Kingdom Seven Life Sciences Full time

Overview:


A Quality and Regulatory team is seeking a full-time, permanent Regulatory Specialist to support the business in maintaining compliance with ISO 13485, Medical Device Directive 93/42/EEC, and Regulation (EU) 2017/745 (EU MDR).


Key Responsibilities:


  • Review, update, and create technical files, and conduct Post Market Surveillance activities for various medical devices.
  • Address internal and external regulatory inquiries.
  • Conduct internal audits.
  • Support the Regulatory Manager and Quality and Regulatory Consultant.


Working Hours:


Monday – Friday (9am – 5pm) (37.5 hours)


Required Experience and Skills:


  • 2 to 5 years of experience in Regulatory Affairs within the medical devices sector, preferably in a commercial setting.
  • Strong knowledge of MDD and MDR.
  • Proficiency in ISO 13485.s
  • Analytical and problem-solving abilities.
  • Excellent written and oral communication skills with high attention to detail.
  • Ability to multitask and prioritize effectively.
  • Integrity and a professional approach to work.
  • A technical background is advantageous.


Desired Experience:


  • Writing post market surveillance
  • Periodic factors
  • Review technical files
  • Clinical evaluations