Quality Assurance Professional

7 days ago


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

Regulatory Affairs & Quality Assurance Consultant

Job Summary:

We are seeking a highly experienced Regulatory Affairs & Quality Assurance Consultant to join our dynamic team at LFH Regulatory Limited. 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.
  • Attend and participate in team meetings, exhibitions, conferences, and network events.

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.
  • 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.

About Us:

LFH Regulatory Limited is a top medical device consultancy company that provides expert regulatory affairs and quality assurance services to clients worldwide. We are committed to helping our clients navigate the complex regulatory landscape and ensure compliance with medical device regulations.



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