Regulatory Affairs Specialist - Medical Devices

About the Role

Our client is seeking an accomplished Regulatory Affairs Specialist with expertise in Medical Devices to bolster their regulatory team in Cardiff . This role is critical in ensuring our client's innovative medical products meet all necessary regulatory requirements for market access across global territories. You will be responsible for preparing and submitting regulatory dossiers, liaising with health authorities, and staying abreast of evolving global regulations. This position offers a unique opportunity to shape the regulatory strategy for a diverse portfolio of cutting-edge medical technologies in the vibrant city of Cardiff .

Key Responsibilities

• Prepare, review, and submit regulatory submissions for new medical devices and product changes to global health authorities (e.g., FDA, EMA, MHRA).
• Ensure compliance with relevant medical device regulations, including MDR, IVDR, and FDA 510(k) requirements.
• Develop and maintain regulatory strategies for product development and lifecycle management.
• Act as a liaison between the company and regulatory agencies, responding to inquiries and managing audits.
• Conduct regulatory intelligence activities to monitor changes in the regulatory landscape and assess their impact.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality, and Marketing.

Requirements

• Bachelor's degree in a scientific, technical, or related field; advanced degree preferred.
• Minimum of 4 years of experience in regulatory affairs , specifically within the medical device industry .
• In-depth knowledge of international medical device regulations (e.g., EU MDR/IVDR, US FDA).
• Experience in preparing and submitting various types of regulatory filings (e.g., 510(k), CE Mark technical files).
• Strong analytical and problem-solving skills, with meticulous attention to detail.
• Excellent written and verbal communication skills, particularly in technical documentation.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive benefits package including private medical insurance and life assurance.
• Pension scheme with company contributions.
• Professional development opportunities and support for certifications.
• A dynamic and collaborative work environment in Cardiff , contributing to improved patient outcomes.