Regulatory Specialist

4 weeks ago


West Yorkshire, United Kingdom Seven Life Sciences Full time

Job DescriptionOverview: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.sAnalytical 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 surveillancePeriodic factorsReview technical filesClinical evaluations



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