Jobs offer

Key responsibilities

1. Prepare and keep technical files up to date in accordance with Regulation (EU) 2017/745 — MDR.
2. Assist in structuring the technical file, including clinical evaluation, risk management, validation/verification data, etc.
3. Work cross-functionally with internal teams on selected projects.
4. Assist the QA/RA team in ensuring the regulatory compliance of NEOLIX medical devices throughout their lifecycle.
5. Liaise with notified bodies and competent authorities.

Qualifications

• Master’s degree, engineering degree or equivalent in biomedical sciences, quality management or another scientific field.
• Proven QA/RA experience in the medical device industry.
• Proven technical file writing background.
• Sound knowledge of EU MDR Regulation and ISO 13485 standards.
• Risk management experience according to ISO 14971.
• Detail-oriented, enterprising, with strong cross-functional skills.
• Strong writing and summarising skills.

Job details

Key responsibilities

1. Assist with the implementation and follow-up of the quality management system — QMS.
2. Manage QMS documentation, including processes, records and updates.
3. Monitor non-conformities, CAPA cases and improvement actions.
4. Support audit preparation and follow-up.
5. Ensure compliance with medical device regulations.
6. Manage product release in accordance with the relevant quality standards.

Qualifications

• Bachelor’s degree in quality management, biotechnology or an equivalent field.
• Initial experience in a similar position is an asset, preferably in the medical device industry.
• Knowledge of ISO 13485 and medical device standards would be appreciated.
• Detail-oriented, organized and analytical.
• Strong interpersonal and teamwork skills.

Job details