Key Responsibilities:
· QMS Implementation/ Maintenance and Regulatory Compliance
- Lead the development, implementation, and continuous improvement of the Quality Management System (QMS) in accordance with relevant standards and regulations.
- Ensure adherence to best practices, streamline processes, and drive innovation in the certification procedures.
- Stay up-to-date with national and international regulatory requirements related to medical device certification and be the key contact for regional colleagues.
- Interpret and communicate regulatory changes to internal stakeholders, ensuring ongoing compliance.
- Working with competent authorities (HSA)
· Regional Synergies Coordination
- Collaborate with regional teams to identify opportunities for synergies and standardization in certification processes.
- Foster communication and collaboration across regions to enhance efficiency and consistency in service delivery.
· Internal Audits
- Plan, support, and oversee internal audits to assess the effectiveness of the QMS.
- Identify areas for improvement, implement corrective actions, and monitor their effectiveness.
· Training Coordination
- Develop and deliver training programs on QMS, regulatory requirements, and certification processes.
- Coordinate regional training sessions to ensure a well-informed and skilled workforce.
Key Requirements:
· Bachelor's degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Engineering).
· Proven experience in implementing and managing Quality Management Systems, preferably in the medical device industry.
· In-depth knowledge of relevant regulations and standards (e.g. ISO 17021 ISO 13485)
· Strong project management and coordination skills.
· Excellent communication and interpersonal skills to work effectively across regional teams.
· Experience in conducting internal audits and driving continuous improvement initiatives.
· Ability to adapt to changes in regulatory landscapes and proactively integrate them into existing processes.
· Travelling in the region (10%)
