Regulatory Affairs Specialist

Responsibilities

• Prepare global regulatory submissions, including US 510(k) and EU technical documentation, and support regional regulatory colleagues in preparing international regulatory submissions for new and modified devices.
• Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to ensure submissions are approved to meet the company’s product launch timelines in all identified markets.
• Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology.
• Provide support for internal and regulatory agency audits.
• Engage directly with regulatory authorities as required.
• Complete regulatory change assessments (e.g., design, labeling, manufacturing process changes) to determine impact on domestic and international product registrations and update registrations accordingly.
• Develop and maintain company Standard Operating Procedures (SOPs) to assure compliance with applicable global regulatory requirements.
• Review product labeling to ensure compliance with regulatory requirements.
• Perform other assigned activities.

Qualifications

• A bachelor’s degree or equivalent experience, ideally in a scientific or technical discipline, with experience in the medical device industry.
• Working knowledge of global medical device regulations, standards and guidance, with hands‑on experience preparing or supporting regulatory submissions.
• Strong communication skills, including technical writing, and the ability to work effectively with cross‑functional and international teams.
• A proactive, analytical, and solution‑focused mindset, with the ability to work independently while contributing positively to a team.
• Curiosity, structure, confidence, and the ability to manage competing priorities in a fast‑paced environment.

Benefits

• Generous annual bonus and pension schemes.
• Save As You Earn share options.
• Hybrid working model (for most professional roles).
• Flexible vacation and time off.
• Paid holidays and paid volunteering hours.
• Private health and dental plans, healthcare cash plans, income protection, life assurance, and more.
• Discounts on gyms and fitness clubs.
• Salary sacrifice bicycle and car schemes.

Inclusion & Belonging

Committed to welcoming, celebrating, and thriving on inclusion and belonging. Learn more about our Employee Inclusion Groups on our website.

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