Regulatory Affairs Specialist Medical Devices

Regulatory Affairs Specialist Medical Device/Health care Industry

We are seeking a Regulatory Affairs Specialist to ensure compliance with global regulations and standards (e.g., MDR, IVDR, ISO) and manage regulatory requirements for our clients products. Key responsibilities include maintaining audit-ready databases, supporting regulatory agency audits, and collaborating with cross-functional teams to manage risks and regulatory changes. The ideal candidate will have a minimum of 3 years' experience in the medical device/health care industry, excellent communication skills, and a strong attention to detail.

Key Responsibilities:

• Champion compliance with global regulations and standards
• Maintain organised regulatory files and audit-ready product databases
• Support and prepare for regulatory agency audits and inspections
• Collaborate with cross-functional teams on risk management and regulatory changes
• Lead strategic quality improvement projects and manage Design Control, Change Control, CAPA, and Risk Management systems

Qualifications:

• Minimum of 3 years' experience in a regulatory role within the medical device/health care industry
• Strong understanding of ISO, MDD v MDR & CE/UKCA
• Excellent communication and people skills
• Analytical mindset with critical thinking abilities
• Ability to work independently and within a team environment

Reach out today for more information on this fantastic role.