Regulatory Affairs and Quality Assurance Specialist

6 days ago


Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time £60,000
Job Description

LFH Regulatory Limited is seeking a highly skilled Regulatory Affairs & Quality Assurance Consultant to join our dynamic team. As a key member of our team, you will be responsible for managing client projects, providing regulatory strategies, and ensuring compliance with medical device regulations.

Key Responsibilities:
  • Manage client projects, including onboarding new clients, creating regulatory strategies, and providing support during audits.
  • Develop and implement quality management systems, including creating procedures, controlled forms, and work instructions.
  • Provide expertise in medical device regulations, including EU MDR, IVDR, and ISO 13485.
  • Collaborate with cross-functional teams to develop crucial regulatory documents.
  • Stay up-to-date with industry developments and advancements in medical device regulation.
Requirements:
  • Minimum of 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device/IVD industry.
  • Proven track record of providing regulatory strategies and ensuring compliance with medical device regulations.
  • Strong knowledge of medical device regulations, including EU MDR, IVDR, and ISO 13485.
  • Experience with device development, quality management systems, audits, technical documentation, risk management, and clinical requirements.
  • Relevant certifications or qualifications in regulatory affairs.
  • Bachelor's degree or higher in a related field.
What We Offer:
  • Competitive salary and compensation package.
  • Opportunities for professional growth and development.
  • Collaborative and dynamic work environment.


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