Medical Regulatory Affairs Specialist

Materialise; Vlaams-Brabant; Hybride; EUR 50 000 - 70 000; Plein temps

Résumé du poste

A leading medical technology company in Leuven is seeking a Medical Regulatory Affairs Specialist. The role involves developing product documentation, interpreting regulations, and liaising with regulatory bodies. Candidates must have at least 3 years of experience in the medical device industry and a master's degree in a relevant field. This full-time position offers a hybrid work model.

Qualifications

• Master’s degree in a relevant scientific discipline (e.g., engineering, pharmacy, bio‑medical sciences).
• At least 3 years of regulatory or equivalent experience in the medical device industry.
• Strong knowledge of European medical device regulations.

Responsabilités

• Develop and maintain technical product documentation for CE-marked and FDA-cleared devices.
• Monitor and interpret medical device regulations and standards.
• Serve as the interface with regulatory agencies during technical file reviews.

Connaissances

Technical writing

Regulatory knowledge

Communication skills

Project management

MS Office proficiency

Formation

Master's degree in a relevant scientific discipline

Description du poste

Medical Regulatory Affairs Specialist at Materialise

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Responsibilities

• Develop and maintain technical product documentation and premarket submissions for CE-marked, FDA-cleared, and custom-made devices; coordinate with internal teams to meet submission deadlines.
• Monitor and interpret European and national medical device regulations and standards, providing guidance to support business operations.
• Serve as the interface with regulatory agencies, such as the FDA, notified bodies, and competent authorities, during technical file review or audits, and ensure timely responses to any inquiries.
• Approve and review labeling and marketing materials for devices within your portfolio.
• Support the enhancement of internal systems and workflows, ensuring alignment with applicable regulations like CE marking and MDSAP.

Qualifications

• Master’s degree in a relevant scientific discipline (e.g., engineering, pharmacy, bio‑medical sciences).
• At least 3 years of regulatory or equivalent experience in the medical device industry.
• Strong knowledge of European medical device regulations and experience developing and maintaining product registration files and technical documentation.
• Strong technical writing and communication skills in English.
• Proficient in MS Office (Word, Excel, PowerPoint).
• Organized, pragmatic, hands‑on, and flexible.
• Able to manage multiple priorities and projects in a global context.

Location and Contract

• Leuven, Belgium
• Full‑time
• Hybrid
• Associate level
• CV in English