Junior RA / QA Specialist – Medical Devices
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- Luxemburg
- Unbefristet
- Vollzeit
- Support the preparation and maintenance of technical files
- Assist with the drafting and review of quality documentation (SOPs, WIs, batch records, etc.).
- Help ensure compliance with regulatory standards.
- Participate in regulatory submissions and notifications on EU and international platforms.
- Assist with non-conformities and change control procedures.
- Participate in audits (internal and external) and implement corrective actions.
- Contribute to the post-market surveillance process and vigilance reports.
- Support RA/QA documentation tracking and digitalisation via SharePoint.
- Coordinate with suppliers and internal departments to ensure documentation completeness.
- Maintain accurate records of product registrations and support communication with distributors and authorities.
- Follow up on trademark and IP portfolio (renewals, surveillance, litigation support).
- Engineering degree (Bac+5) or equivalent, ideally in biomedical, biologist, pharmaceutical, chemistry or related fields.
- First professional experience (2–3 years max) in, QA, or industrial/laboratory setting and Regulatory Affairs.
- Familiarity with Medical Device regulations (MDD93/42, MDR17/745), ISO 13485, and quality documentation processes.
- Strong writing, analytical, and communication skills.
- Fluency in English (French is a plus).
- Experience using Microsoft Office, SharePoint, and digital platforms (ERP, Power BI) is an asset.
- Organised, detail-oriented, and able to handle multiple tasks.
- A permanent role in a fast-growing international company.
- A dynamic, multicultural, and innovative work environment.
- Direct exposure to regulatory and quality processes in the Medical Device sector.
- Opportunities for professional development and growth.
- A collaborative and human-centred culture that values learning and initiative.
- An attractive salary package aligned with your profile.
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