Affaires Reglementaires jobs in Bahrain

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Beyond Conception GmbH

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69177547883020288327647

1

15.05.2025

29.06.2025

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As a Senior Regulatory Affairs (RA) Consultant, you will play a pivotal role in supporting pharmaceutical and medical device clients in the development, submission, and lifecycle management of drug-delivery devices and combination products. Your responsibilities include leading regulatory projects, advising on strategies and pathways, collaborating with R&D teams, and ensuring compliance for market entry and maintenance in key regions such as the EU and US. Key responsibilities:

1. Develop and implement regulatory strategies for drug-delivery devices and combination products.
2. Provide guidance on regulatory classifications and submission pathways for the EU (MDR, CE Marking) and US (FDA, 510(k), PMA, NDA, BLA, ANDA).
3. Support R&D teams during development, from design control to quality management, ensuring regulatory compliance.
4. Compile dossiers and technical documentation for submissions, liaising with stakeholders and notified bodies.
5. Manage communications with authorities, participate in audits and inspections.
6. Mentor colleagues and contribute to internal training.

Your profile:

• Independent, proactive, with a passion for regulatory projects.
• Experienced in drug-delivery devices and combination products under EU and US frameworks.
• Knowledge of Quality Management Systems (ISO 13485, MDR, 21 CFR 820/QSR, ISO 14971).
• Skilled in device development, technical standards, and cross-functional collaboration.
• Proven track record in managing projects and stakeholder relationships.
• Experience with audits and inspections.
• Degree in Biomedical Engineering, Pharmacy, or related field.
• Fluent in English; French is a plus.