Senior Quality Management R&D Specialist (m/w/d)

Proclinical is seeking a Sr. Quality Management Research & Discovery Specialist to join a dynamic team in the medical devices sector. This role focuses on leading global R&D projects and ensuring compliance with quality management standards. Your expertise will be crucial in managing risk and safety requirements within the gastroenterology field.

Key Responsibilities:

1. Taking the lead on global R&D projects as the Quality Management Lead
2. Overseeing Risk Management activities for R&D projects
3. Serving as the key expert on basic safety and essential performance requirements
4. Managing and tracking CAPA, non-conformities, and planned deviations
5. Representing Ambu during Notified Body audits and regulatory inspections

Candidate Profile:

1. A BSc or MSc in a relevant field, coupled with at least five years of experience in a highly regulated industry
2. Extensive knowledge of regulatory and quality standards for medical devices, including risk management, quality management systems, and safety regulations (e.g., ISO 14971, ISO 13485, EU MDR, MDSAP, UK MD)
3. A strong commitment to quality management and a proactive approach to business partnering within the organization
4. An outgoing personality with solid business acumen and the ability to clearly communicate quality requirements while ensuring seamless implementation in a global setting

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV.

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