Regulatory Compliance Consultant
4 weeks ago
Are you a seasoned professional in regulatory affairs and quality assurance seeking a new opportunity? If so, we invite you to explore this role.
LFH Regulatory Limited, a leading consultancy in the medical device sector, is in search of a Regulatory Affairs & Quality Assurance Consultant for a fixed-term contract. This position offers the flexibility of remote work with occasional travel requirements.
About Us: We collaborate with a variety of companies across diverse technologies, providing a stimulating work environment that fosters professional growth and development.
Our Services Include:
- Device development and CE/UKCA marking certification
- Global regulatory strategies and US FDA compliance
- Quality management system development and ISO 13485 support
- Internal and supplier audits
- Technical documentation and risk management in accordance with ISO 14971
- Clinical requirements and adverse event management
- Product registration and UK Responsible Person services
Role Overview:
The Regulatory Affairs & Quality Assurance Consultant will take on client-facing responsibilities, including:
- Onboarding new clients and identifying business opportunities during meetings
- Participating in client meetings, both virtually and in-person as required
- Developing regulatory strategies for international markets, including medical device and IVD classification
- Creating and maintaining technical file documentation, including:
- Risk management plans
- Post-market surveillance strategies
- Essential Requirements Checklists (ERCs) and General Safety and Performance Requirements (GSPRs)
- Clinical and biological evaluations
- Usability engineering documentation
- Labeling and instructions for use
- Applicable standards
- Registering devices with relevant regulatory authorities
- Preparing UK Responsible Person documentation
- Engaging with Notified/Approved Bodies and Competent Authorities
- Providing comprehensive support to clients throughout the audit process, including preparation and addressing non-conformities.
LFH Responsibilities:
- Participating in team meetings, both remote and in-person
- Reviewing and providing feedback on client documentation prepared by colleagues
- Creating content for our website and social media platforms as needed
- Updating and maintaining internal regulatory processes and training records
- Attending industry exhibitions, conferences, and networking events.
Essential Qualifications:
- 3-5 years of experience in regulatory affairs and/or quality assurance within the medical device or IVD sector
- A proactive attitude towards learning and development
- Strong problem-solving capabilities
- In-depth knowledge of medical device regulations, including EU MDR, IVDR, and ISO 13485
- Experience in device development, quality management systems, audits, and technical documentation
- Excellent communication and interpersonal skills
- Ability to work independently and collaboratively
- Attention to detail and strong analytical skills
- Relevant certifications in regulatory affairs
- A Bachelor's degree or higher in a related field.
Desired Qualifications:
- Experience with US FDA regulations
- Familiarity with Software as a Medical Device (SaMD)
- Experience in implementing quality management systems through procedure development.
Benefits:
Competitive Salary: We recognize the value of your expertise and offer a competitive salary package.
Professional Development: This role provides opportunities to work on a variety of projects, enhancing your skills and knowledge in medical device regulation.
Dynamic Work Environment: Join a team dedicated to advancing medical technology, where you will face new challenges and opportunities daily.
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