Regulatory Affairs & Clinical Consultant
Remote
Role Summary:
A leading consultancy in the medical device sector is seeking a Regulatory Affairs & Clinical Consultant to provide expert guidance on regulatory and clinical requirements for medical devices and in vitro diagnostics (IVDs). This role offers an exciting opportunity to work on diverse projects, collaborate with cross-functional teams, and contribute to regulatory compliance in a dynamic and evolving environment.
As a key member of the consultancy team, you will engage with clients to develop regulatory strategies, compile technical documentation, and support compliance with global regulatory requirements. The role is available on a full-time or part-time basis (3 to 5 days per week) and is fully remote with occasional travel.
Key Responsibilities:
Regulatory Strategy & Compliance
Develop and implement regulatory strategies for global markets, including device classification for medical devices and IVDs.
Prepare and maintain technical documentation, including risk management, post-market surveillance, clinical evaluation, and biological evaluation.
Ensure compliance with CE/UKCA marking, FDA regulations, and other relevant regulatory frameworks.
Register medical devices with regulatory authorities and liaise with Notified/Approved Bodies and Competent Authorities.
Provide guidance on regulatory requirements, including ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
Client Collaboration & Project Management
Act as a key point of contact for clients, providing regulatory and clinical consulting services.
Onboard new clients and explore business opportunities during client interactions.
Conduct gap assessments on technical documentation and recommend compliance improvements.
Support clients before, during, and after audits, including audit preparation and non-conformity resolution.
Review and prepare documentation for UK Responsible Person services.
Quality & Process Improvement
Contribute to the enhancement of quality management systems and regulatory processes.
Assist clients in addressing audit findings and improving regulatory documentation.
Support continuous improvement initiatives in regulatory affairs and clinical evaluation practices.
Qualifications & Experience:
Education & Background
Degree in a scientific, engineering, or medical discipline, or equivalent industry experience.
Minimum of 2 years’ experience in regulatory and clinical affairs within the medical device/IVD sector.
Skills & Knowledge
Expertise in compiling and reviewing clinical/performance evaluation documentation and technical files.
Strong understanding of regulatory requirements, including CE/UKCA marking and international compliance frameworks.
Familiarity with ISO 13485, ISO 14971, and FDA regulations.
Ability to assess and communicate regulatory obligations effectively.
Excellent attention to detail and problem-solving skills.
Strong communication and interpersonal skills.
Commercial awareness and ability to engage with stakeholders at all levels.
What’s in it for you?
Competitive salary, based on experience.
Company-based bonus scheme.
Flexible working options, including part-time availability.
Opportunities for professional growth in a rapidly expanding consultancy.
Work on diverse projects with cutting-edge medical technologies.
Fully remote role with occasional travel.
Collaborative and stimulating work environment within a dynamic industry.
This is an excellent opportunity for a regulatory and clinical professional seeking a challenging and rewarding role in the medical device sector. If you are ready to take the next step in your career, we would love to hear from you!