Regulatory Affairs Specialist

3 weeks ago

Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time
Job Title: Regulatory Affairs & Quality Assurance Consultant

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, creating regulatory strategies, and providing support to clients pre, during, and post-audit.

Key Responsibilities:
  • Manage client projects, including onboarding new clients and creating regulatory strategies for global markets.
  • Provide support to clients pre, during, and post-audit, including audit preparation, attending audits, and assisting with non-conformities.
  • Register devices with regulatory authorities and create, maintain, and conduct gap assessments on technical file documentation for clients.
  • Collaborate with cross-functional teams to develop crucial regulatory documents that impact the advancement of medical technology.
Requirements:
  • Minimum of 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device/IVD industry.
  • In-depth knowledge of medical device regulations and standards, 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.
  • Professional growth and development opportunities.
  • Collaborative and dynamic work environment.

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