BioTalent have partnered with a fast-growing Medical Device organization at an exciting period entering ramp up of commercialization. Our client specialises in the area of oncology and is focused on developing break-through non-invasive therapies.

The business currently markets their products in Europe, Australia and Africa, and is in the process of securing US entry.

Responsibilities

• Ensure QMS requirements are established and maintained.
• Work and mentor junior QA peers.
• Assists preparations and negotiations with regulatory authorities and notified bodies in new markets (FDA) and act as a key contact for authorities in existing markets.
• Participate in internal and external audits, and regulatory inspections.
• Perform review and management of SOPs and other Quality Management documents.
• Management of technical documentation for submissions and product changes.
• Involvement in process optimization for QARA processes.
• Responsibility for global QARA compliance.

Skills/Qualifications

• Educational background in engineering or science related discipline.
• Minimum of 4 years’ experience in Quality and Regulatory affairs for medical devices.
• Prior FDA interaction, ideally 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 is desirable.

If you are interested in this position, apply now or contact Anita Osibuamhe at anita.osibuamhe@biotalent.com or +44 20 3862 2742 for a confidential conversation today.