Technical Standards & Regulatory Affairs Engineer

We are looking for a Technical Standards & Regulatory Affairs Engineer to support one of our clients active in the high-tech industry. The consultant will play a key role in ensuring that products and processes comply with applicable technical standards and regulatory requirements across relevant markets.

• Identify, analyse, and monitor applicable technical standards and regulatory requirements (international and sector-specific)
• Support product development and engineering teams in integrating compliance requirements from early design stages
• Lead and coordinate regulatory submissions and technical documentation packages
• Maintain and update the regulatory affairs database and standards library
• Liaise with regulatory bodies, notified bodies, and standards organisations
• Provide internal training and guidance on regulatory and standards compliance
• Participate in audits and support corrective action processes

• Engineering degree (electromechanical, biomedical, physics, or equivalent)
• Experience in regulatory affairs or technical standards within a high-tech, medical device, or industrial environment
• Familiarity with standards such as IEC, ISO, CE marking, FDA requirements (an asset)
• Strong analytical and documentation skills
• Fluent in English; French and/or Dutch is a plus
• Ability to work in a structured, process-driven environment