Regulatory Affairs Specialist – Medical Devices

Overview

In this role, you support regulatory activities across the business, collaborating with engineers and scientists to align development with global requirements. You will help operate the quality management system and guide teams through evolving standards, enabling innovation with compliance. The position offers exposure to medical and non-medical sectors, shaping how technologies reach the market. You will work closely with cross‑functional teams to implement regulatory strategies and drive improvements in processes.

Responsibilities

• Provide regulatory support across the business and assist senior QA/RA with QMS operation
• Monitor and interpret changes in international regulations and standards and communicate updates to colleagues
• Contribute to internal improvement initiatives and support external audit activities
• Ensure quality and regulatory processes remain robust, efficient, and aligned with business needs
• Balance creative problem‑solving with disciplined, regulated product development
• Build relationships across a wide range of stakeholders and own regulatory initiatives
• Develop or contribute to regulatory strategies and ensure downstream processes reflect regulatory implications

Key requirements

• Experience developing or contributing to regulatory strategies
• Ability to interpret regulatory requirements and understand downstream implications
• Knowledge of medical device compliance
• Strong, independent working style with the ability to support others
• Clear communication and stakeholder management skills
• Experience across lifecycle—development through commercial release
• Awareness of ISO 9001, ISO 13485 and FDA 21 CFR 820 expectations

• strong communication
• independence
• relationship building
• Regulatory strategies for medical devices
• Regulatory requirements interpretation
• ISO 9001

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