Quality Assurance Consultant

3 weeks ago

Huddersfield, Kirklees, United Kingdom LFH Regulatory Limited Full time

Are you a seasoned professional in regulatory affairs and quality assurance seeking a rewarding opportunity? Look no further.

LFH Regulatory Limited, a leading consultancy in the medical device sector, is on the lookout for a Regulatory Affairs & Quality Assurance Consultant. This role is designed as a fixed-term contract, offering the potential for extension, and is fully remote with occasional travel requirements.

About Us:

At LFH, we collaborate with a variety of companies across diverse technological landscapes, providing a stimulating work environment that fosters professional growth and development. Our expertise spans device development, CE/UKCA marking certification, global regulatory strategies, and comprehensive quality management systems.

Key Responsibilities:

  • Engage with clients to manage projects effectively, including onboarding new clients and identifying business opportunities.
  • Participate in client meetings, both virtually and in-person, as necessary.
  • Develop regulatory strategies tailored for global markets, focusing on the classification of medical devices and IVDs.
  • Conduct thorough assessments and maintain technical file documentation for clients, covering:
    • Risk management
    • Post-market surveillance
    • Essential Requirements Checklists (ERCs) and General Safety and Performance Requirements (GSPRs)
    • Clinical and Biological Evaluations
    • Usability Engineering
    • Labeling and Instructions for Use
  • Facilitate device registration with regulatory authorities and prepare UK Responsible Person documentation.
  • Coordinate with Notified/Approved Bodies and Competent Authorities.
  • Support clients throughout the audit process, including preparation, attendance, and addressing non-conformities.

Team Contributions:

  • Engage in team meetings, both remotely and face-to-face.
  • Review and provide constructive feedback on documentation prepared by colleagues.
  • Create engaging content for our website and social media platforms.
  • Maintain and update internal regulatory processes and employee training records.
  • Represent LFH at exhibitions, conferences, and networking events.

Qualifications:

Essential:

  • 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device or IVD industry.
  • A proactive approach to learning and professional development.
  • Strong problem-solving abilities and project management skills.
  • Comprehensive knowledge of medical device regulations, including EU MDR, IVDR, and ISO 13485.
  • Experience in quality management systems, audits, technical documentation, and clinical requirements.
  • Excellent communication and interpersonal skills.
  • Ability to work independently and collaboratively within a team.
  • Attention to detail and strong analytical capabilities.
  • Relevant certifications in regulatory affairs.
  • A Bachelor's degree or higher in a related field.

Preferred:

  • Experience with US FDA regulations.
  • Familiarity with Software as a Medical Device (SaMD).
  • Experience in implementing quality management systems.

What We Offer:

Competitive Compensation: We recognize the value of your expertise and offer a competitive salary package.

Professional Development: As a Regulatory Affairs & Quality Assurance Consultant, you will engage in diverse projects that enhance your skills and broaden your knowledge in medical device regulation.

Dynamic Work Environment: Join a team at the forefront of medical device regulation, where you will face new challenges and opportunities daily.

We invite you to explore this exciting opportunity with us.

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