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ÌìÑÄÉçÇø¹ÙÍø 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:

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

Candidate Profile

• A BSc or MSc in a relevant field, coupled with at least five years of experience in a highly regulated industry
• 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)
• A strong commitment to quality management and a proactive approach to business partnering within the organization
• 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 having difficulty in applying or if you have any questions, please contact Jana Birli at j.birli@proclinical.com.

Apply Now:

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. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

ÌìÑÄÉçÇø¹ÙÍø is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ÌìÑÄÉçÇø¹ÙÍø is acting as an Employment Agency in relation to this vacancy.