Technical Standards & Regulatory Affairs Engineer

ELMEA Consulting Group; Brussel Hoofdstad; Sur place; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A consulting firm specializing in regulatory affairs is seeking a Technical Standards & Regulatory Affairs Engineer in Brussels, Belgium. The successful candidate will ensure that products comply with technical standards, support product development teams, and manage regulatory submissions. An engineering degree and experience in regulatory affairs are required. Fluency in English is essential; knowledge of French or Dutch is advantageous. Join a dynamic team in the high-tech industry.

Qualifications

• Experience in regulatory affairs or technical standards within high-tech or medical device environments.
• Ability to work in a structured, process-driven environment.
• Fluency in French and/or Dutch is a plus.

Responsabilités

• Identify, analyse, and monitor applicable technical standards.
• Support product development with compliance requirements.
• Lead regulatory submissions and documentation.
• Maintain and update the regulatory affairs database.
• Liaise with regulatory and standards organizations.
• Provide internal training on regulatory compliance.
• Participate in audits and support corrective actions.

Connaissances

Analytical skills

Documentation skills

Fluent in English

Familiarity with IEC, ISO, CE marking

Formation

Engineering degree (electromechanical, biomedical, physics, or equivalent)

Description du poste

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

Required profile.

• 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

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