Medical Device Post-Market Surveillance Specialist
1 week geleden
Santen is seeking a highly skilled Post-Market Surveillance Medical Device Manager to join our team. As a key member of our organization, you will be responsible for ensuring the safe and effective use of our medical devices globally.
Key Responsibilities- Develop and implement global harmonization of post-market surveillance, clinical studies, and vigilance processes for medical devices in collaboration with the Safety Vigilance department.
- Provide regulatory intelligence monitoring and update internal processes 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.
- Lead Joint Vigilance and Quality Committee and other PMS meetings to manage risk and product quality in collaboration with Quality Assurance and Manufacturers.
- Support regional/local teams to establish local specific medical device activities.
- Contribute and review the Quality and Safety Vigilance agreement with (external) partners.
- Correspond 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 labeling and risk management with product safety leads.
- Preferably a university degree in the Life Science field.
- Fluent written and oral command of 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.
Santen is a Social Innovator addressing the social and economic needs of people with visual impairments. We are committed to building diverse teams and ensuring a safe and inclusive physical and virtual workplace for every one of our team members.
We are an Equal Opportunity Employer and welcome applications from all qualified candidates.
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Medical Device Post-Market Surveillance Specialist
1 week geleden
Amsterdam, Noord-Holland, Nederland Santen Voltijd{"title": "Post-Market Surveillance Medical Device Manager", "description": "Job OverviewSanten is seeking a highly skilled Post-Market Surveillance Medical Device Manager to join our team. As a key member of our organization, you will be responsible for ensuring the safe and effective use of our medical devices globally.Key ResponsibilitiesDevelop and...
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