Regulatory Affairs Specialist - Medical Devices

About the Role

Our client, a forward-thinking medical device company, is seeking a highly competent Regulatory Affairs Specialist to join their expanding team. Operating remotely from Edinburgh , you will be instrumental in ensuring that their innovative medical devices meet all global regulatory requirements for market entry and compliance. This role involves navigating complex international regulations, preparing submission dossiers, and liaising with health authorities. It is an ideal opportunity for a seasoned regulatory professional to contribute to bringing critical healthcare technologies to patients worldwide, working within a flexible, remote-first culture.

Key Responsibilities

• Prepare, review, and submit regulatory documentation for medical devices to global health authorities (e.g., FDA, EMA, MHRA).
• Develop and implement global regulatory strategies for new and existing products.
• Monitor and interpret evolving regulatory landscapes and guidance documents.
• Liaise directly with regulatory agencies during the submission and review processes.
• Ensure compliance with relevant medical device regulations, including MDR and IVDR.
• Support post-market surveillance activities and manage regulatory reporting requirements.

Requirements

• Bachelor's or Master's degree in a scientific, technical, or regulatory field.
• Minimum of 4 years of experience in Regulatory Affairs within the medical device industry.
• In-depth knowledge of international medical device regulations (e.g., FDA 21 CFR Part 820, EU MDR 2017/745).
• Proven experience in preparing and submitting regulatory dossiers for CE marking and FDA 510(k) submissions.
• Excellent written and verbal communication skills, with strong attention to detail.
• Ability to work autonomously and manage multiple projects simultaneously in a remote environment .

Benefits

• Competitive salary and potential for performance-based bonuses.
• Fully remote working position with flexible hours.
• Comprehensive medical, dental, and vision insurance benefits.
• Generous paid time off and paid holidays.
• Opportunities for continuous professional development and training in a rapidly evolving field.