Senior Quality Assurance Specialist
vor 3 Wochen
As the Senior Quality and Regulatory Affairs Manager at BioTalent, you will play a critical role in ensuring the company's products meet the highest standards of quality and regulatory compliance.
Our client specializes in oncology and is focused on developing breakthrough non-invasive therapies. They currently market their products in Europe, Australia, and Africa, and are in the process of securing US entry.
- Responsibilities
- Establish and maintain QMS requirements.
- Mentor junior QA peers and assist with regulatory authority interactions.
- Participate in internal and external audits, and regulatory inspections.
- Review and manage SOPs and other Quality Management documents.
- Manage technical documentation for submissions and product changes.
- Involvement in process optimization for QARA processes.
- Ensure global QARA compliance.
Requirements
- Engineering or science-related educational background.
- Minimum 4 years of experience in Quality and Regulatory Affairs for medical devices.
- Prior FDA interaction, preferably with submission and technical documentation for 510k/De Novo processes.
- Knowledge of ISO 13485, MDR, and ISO 9001.
- Experience with risk management.
- Fluency in English required, B2 level of German desirable.
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