* please only apply if you are located in Netherlands*
Job’s mission
Ensuring, coordinating and harmonizing pre- and post-market surveillance activities to achieve 100% compliance globally and maintain safe and performance devices.
Key Responsibilities & Accountabilities
- Contribute to the development and implementation of global harmonization of post-market surveillance, clinical studies and vigilance processes for medical devices in collaboration with Safety Vigilance department.
- Will be the first point of contact for Safety Vigilance for all reporting activities, clinical studies, Eudamed implementation and other questions concerning medical devices.
- Conduct regulatory intelligence monitoring and keep updating internal process as per regulatory requirements for PMS globally in collaboration with Safety Vigilance
- Contribute to the implementation and maintenance of the IMDRF code system in collaboration with Safety Vigilance and Quality Assurance.
- Leads Joint Vigilance and Quality Committee and others PMS meeting to manage risk and product quality in collaboration with Quality Assurance and Manufacturers.
- Provide supports to regional/local teams to establish local specific medical device activities.
- Contribute and review the Quality and Safety Vigilance agreement with (external) partners.
- Corresponds to the inspection/audit as a representative of PMS manager for medical device management.
- Collect, trend, and monitor medical device safety data.
- Generate Post Market Surveillance reports by compiling data collected from various sources such as product quality data, safety data, feedback, literature reviews.
- Provide training in relation to Post Market Activities for medical devices
- Support review labelling and risk management with product safety leads.
- Preferably a university degree in the Life Science field
- Fluent written and oral command English is a must (French is a plus)
- In depth knowledge of regional/local regulatory guidelines and regulation for Medical devices
- Minimum 3-5 years in medical device industry experience
- At least 1 year experience in Regulatory Affairs or Quality Assurance
- Experience in Medical Writing and data analysis
- Experience of working in a cross functional function and multicultural environment
- Excellent communication skills with stakeholders including regulatory authorities
Grow your career at Santen
A career at Santen is an opportunity to make a difference. Through our long-term vision outlined in Santen 2030, we are committed to be a Social Innovator - addressing the social and economic needs of people with visual impairments. We have team members around the world using their diverse talents to unlock new modalities and drive innovations for patient outcomes, education and treatment. At Santen, we believe in empowering all our team members with flexible ways of working and a highly inclusive work environment.
The Santen Group is an Equal Opportunity Employer. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members. All employment decisions are based on business needs, role requirements and individual qualifications regardless of race, color, ethnicity, national origin/ancestry, religion, sexual orientation, gender, gender identity/ expression, age, disability, medical condition, marital status, veteran status, or any other characteristic protected by law.
Santen SA, the Netherlands Branch has an exclusive arrangement for recruitment services. External recruiting agencies are kindly requested not to contact us regarding the positions listed here.
If you require any kind of accommodation during our recruitment process, please let the recruiter from our team know.
