Regulatory Affairs Specialist - Medical Devices

About the Role

Our client is seeking a meticulous and knowledgeable Regulatory Affairs Specialist to join their team in Cardiff . This role focuses on ensuring compliance with national and international regulations for their portfolio of medical devices. You will be instrumental in preparing and submitting regulatory documentation, liaising with regulatory authorities, and staying abreast of evolving regulatory landscapes. This position offers a blend of remote and office-based work, providing flexibility while fostering collaboration within a dedicated regulatory affairs department that is pivotal to the company's product lifecycle.

Key Responsibilities

• Prepare, review, and submit regulatory submissions for new and modified medical devices to various global health authorities.
• Ensure all regulatory documentation and technical files meet current standards and comply with relevant directives and regulations (e.g., MDR, FDA).
• Act as a primary contact for regulatory agencies during reviews and audits.
• Monitor changes in the regulatory environment and assess their impact on the company's products and processes.
• Collaborate with R&D, Quality Assurance, and Marketing teams to ensure regulatory requirements are integrated into product development.
• Develop and implement regulatory strategies to facilitate market access and product approval.

Requirements

• Bachelor's degree in a relevant scientific or technical field (e.g., Engineering, Biology, Chemistry).
• Minimum of 3 years of experience in regulatory affairs, specifically within the medical device industry.
• Strong understanding of global medical device regulations, including the EU MDR and FDA 510(k) processes.
• Experience with technical documentation and submission preparation.
• Excellent analytical, written, and verbal communication skills.
• Ability to manage multiple projects simultaneously and work effectively in a hybrid environment.

Benefits

• Competitive annual salary and performance incentives.
• Generous hybrid working policy with flexible hours.
• Comprehensive healthcare package including private medical and dental cover.
• Pension scheme with company match.
• Support for professional development and continuous learning in regulatory affairs.