Regional Quality & Regulatory Specialist (OLYMPUS)

Olympus is a worldwide leading manufacturer of optical and digital precision technology and provides innovative solutions for state-of-the-art medical systems, digital cameras as well as scientific solutions. For 100 years, Olympus has consistently developed break-through, category-leading products and solutions that have shaped the industry and, more importantly, made people’s lives healthier, safer and more fulfilling.

As our Regional Quality & Regulatory Specialist, you will work hands-on in the areas of Quality Management and Regulatory Affairs across Olympus’ North region comprising of the Nordics, Baltics and the Netherlands. You will
be stationed in Tallinn but will work closely with colleagues throughout the region. This position is new to Olympus, and therefore you will be a key player in ensuring that the processes function and standards and regulations are
being followed.

Quality Management
- Co-develop and maintain the Regional Quality Management System (Updating Quality Management System related documents, support in creation of Management reports, ensuring compliance of third-party suppliers,
etc.)
- Coordinate Corrective Actions and Preventive Actions (CAPA) activities in the region
- Conduct training for employees (on-boarding) of new employees, refreshment trainings or changing requirements to processes)
- Support in organizing and conducting local and regional audits, meetings, trainings

Regulatory Affairs
- Support coordinating Field Service Corrective Actions (FSCA) activities on the region
- Monitor product complaint process, including Potential Adverse Events (PAE). Implement corrections if necessary
- Identify potential changes to regulations, review impact, notify business and support implementation to ensure compliance is maintained

- Relevant degree in scientific/engineering or business administration
- Experience in relevant administrative/coordinating role in the area of regulatory and/or quality for preferably medical devices
- Knowledge of relevant standards, laws & regulations (e.g ISO 9001/13485, MDD/MDR)
- Estonian and English (professional working proficiency)
- Excellent organizational skills and attention to detail
- Excellent oral and written communication skills