Your responsibilities

In this role, you will:

• Ensure compliance with applicable regulatory requirements, standards and internal processes, translating requirements into effective ways of working.
• Establish, maintain and continuously improve the Quality Management System and related processes in line with international regulatory requirements and standards.
• Provide quality assurance expertise to support product design and development activities.
• Participate in product and process risk assessments.
• Review product design documentation from a quality and regulatory perspective.
• Review and approve Corrective and Preventive Actions (CAPAs) and complaint-related activities to support compliance.
• Promote awareness and understanding of quality system and regulatory requirements across the organization.
• Support appropriate product licensing and compliance with legal and standards requirements in target medical device markets.
• Conduct internal audits and coordinate or host external audits.
• Maintain the company's library of relevant regulatory and standards resources.

Your Profile - Qualifications

Essential

• A Master’s degree in a relevant scientific or technical field with at least 2 years of relevant experience, or a Bachelor’s degree in a relevant technical field with at least 4 years of relevant experience.
• At least 3 years of experience working in a regulated medical device environment.
• Practical knowledge of EU and US medical device regulations, including the EU Medical Device Regulation (MDR) and 21 CFR Part 820.
• Knowledge of relevant ISO and IEC standards, such as ISO 13485, ISO 14971, IEC 62304 and IEC 62366-1.
• Experience conducting audits.
• Strong written and spoken English, including the ability to communicate regulatory information clearly and accurately.
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