Regulatory Affairs Specialist
4 weeks ago
Are you a skilled professional in regulatory affairs and quality assurance seeking a new opportunity? Look no further.
LFH Regulatory Limited is a leading consultancy in the medical device sector, currently in search of a Regulatory Affairs & Quality Assurance Consultant for a fixed-term engagement. This role offers the flexibility of remote work with occasional travel requirements.
Our consultancy provides a wide array of services, including device development, CE/UKCA marking certification, global regulatory strategies, and comprehensive support for quality management systems. We also focus on internal and supplier audits, remediation of audit findings, technical documentation, risk management activities, clinical requirements, and product registration.
Key Responsibilities:
The Regulatory Affairs & Quality Assurance Consultant will undertake various client-facing tasks, including:
- Onboarding new clients and identifying business opportunities during meetings.
- Participating in both remote and onsite client meetings as necessary.
- Formulating regulatory strategies for international markets, including the classification of medical devices and IVDs.
- Developing and conducting gap assessments on technical file documentation, which encompasses:
- Risk management
- Post-market surveillance
- Essential Requirements Checklist (ERCs) and General Safety and Performance Requirements (GSPRs)
- Clinical Evaluation
- Biological Evaluation
- Usability Engineering
- Instructions for use and labels
- Applied standards
- Registering devices with relevant regulatory authorities.
- Reviewing and preparing documentation for UK Responsible Person requirements.
- Collaborating with Notified/Approved Bodies and Competent Authorities.
- Providing comprehensive support to clients before, during, and after audits, including preparation and assistance with non-conformities.
LFH Responsibilities:
As part of the LFH team, you will be expected to:
- Engage in team meetings, both virtually and in person.
- Review and provide constructive feedback on documentation prepared by colleagues.
- Create content for our website and social media platforms as needed.
- Maintain and update internal regulatory business processes and training records.
- Participate in industry exhibitions, conferences, and networking events.
Qualifications:
Essential:
- A minimum of 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 professional development.
- Strong problem-solving capabilities, with an ability to anticipate issues and drive consensus.
- In-depth knowledge of medical device regulations, including EU MDR, IVDR, and ISO 13485.
- Experience in device development, quality management systems, audits, technical documentation, and risk management.
- Excellent communication and interpersonal skills.
- Strong attention to detail and analytical skills.
- A relevant degree or certification in regulatory affairs.
Desired:
- Experience with US FDA regulations.
- Familiarity with Software as a Medical Device (SaMD).
- Experience in implementing quality management systems.
Benefits:
Competitive Salary: 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 knowledge in medical device regulation.
Dynamic Work Environment: Join a team that is at the forefront of medical device regulation, where each day presents new challenges and opportunities to contribute to the advancement of medical technology.
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