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We are seeking a highly skilled Medical Device Manager to join our team at Santen. As a key member of our organization, you will be responsible for ensuring the safe and effective management of medical devices globally.
Key Responsibilities- Regulatory Compliance: Develop and implement global harmonization of post-market surveillance, clinical studies, and vigilance processes for medical devices in collaboration with the Safety Vigilance department.
- Reporting and Intelligence: Serve as the first point of contact for Safety Vigilance for all reporting activities, clinical studies, Eudamed implementation, and other questions concerning medical devices.
- Process Improvement: Conduct regulatory intelligence monitoring and update internal processes as per regulatory requirements for PMS globally in collaboration with Safety Vigilance.
- Quality Management: Contribute to the implementation and maintenance of the IMDRF code system in collaboration with Safety Vigilance and Quality Assurance.
- Leadership and Collaboration: Lead Joint Vigilance and Quality Committee and other PMS meetings to manage risk and product quality in collaboration with Quality Assurance and Manufacturers.
- Regional Support: Provide support to regional/local teams to establish local specific medical device activities.
- Partnership and Communication: Contribute and review the Quality and Safety Vigilance agreement with (external) partners.
- Inspection and Audit: Correspond to the inspection/audit as a representative of PMS manager for medical device management.
- Data Analysis: Collect, trend, and monitor medical device safety data.
- Reporting and Documentation: Generate Post Market Surveillance reports by compiling data collected from various sources such as product quality data, safety data, feedback, literature reviews.
- Training and Development: Provide training in relation to Post Market Activities for medical devices.
- Labeling and Risk Management: Support review labeling and risk management with product safety leads.
- Education: Preferably a university degree in the Life Science field.
- Language Skills: Fluent written and oral command of English is a must (French is a plus).
- Regulatory Knowledge: In-depth knowledge of regional/local regulatory guidelines and regulation for Medical devices.
- Experience: Minimum 3-5 years in medical device industry experience.
- Regulatory Affairs: At least 1 year experience in Regulatory Affairs or Quality Assurance.
- Medical Writing and Data Analysis: Experience in Medical Writing and data analysis.
- Cross-Functional Experience: Experience of working in a cross-functional function and multicultural environment.
- Communication Skills: Excellent communication skills with stakeholders including regulatory authorities.
