Netherlands Job Openings
![Santen [The Netherlands] PMS Medical Device Manager](/storage/logo/Santen.jpeg){kind=logo}
Santen
[The Netherlands] PMS Medical Device Manager
Amsterdam
FULL TIME
September 4, 2024
Santen is a specialized life sciences company with a proud 130-year heritage focused exclusively on ophthalmology. As a Japan-originated, global company with our footprint in over 60 countries, we are dedicated to delivering innovative treatments and digital solutions for eye health and addressing vision-related social issues for people around the world.
Job Description
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.
Qualifications
- 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
Additional Information
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.
New Job Alerts
Lab Digital
DevOps Cloud Engineer (Azure)
Utrecht
FULL TIME & PART TIME
September 23, 2024
View Job Description
JD Sports Netherlands
Payroll Specialist (m/f/d) Parttime
Amsterdam
PART TIME
September 23, 2024
View Job Description
Maastricht University
PhD Candidate: Harnessing heterosis in Pea (Pisum sativum) for sustainable, alternative protein
Venlo
FULL TIME
September 23, 2024
View Job Description
Vrije Universiteit Amsterdam
Postdoc position in Fungal Ecology & Fungal Biology
FULL TIME
September 23, 2024
View Job DescriptionVertico
Business Development Manager
Eindhoven
FULL TIME & CONTRACT
September 23, 2024
View Job Description
Maastricht University
PhD candidate at the Instituut MERLN
Maastricht
FULL TIME
September 23, 2024
View Job Description
Michael Page
(Sr.) Recruitment Consultant - MichaelPage Tilburg
Tilburg
September 23, 2024
View Job Description
Page Personnel
(Sr.) Recruitment Consultant - PagePersonnel Utrecht
Utrecht
September 23, 2024
View Job Description
CBOE
Senior Legal Counsel (12 Month FTC - Maternity Cover)
FULL TIME
September 23, 2024
View Job DescriptionLooking for similar job?
Santen
[The Netherlands] Manager, Supplier Quality Assurance
Amsterdam
FULL TIME
September 2, 2024
View Job Description
Santen
[The Netherlands] Manager, Supplier Quality Assurance
Amsterdam
FULL TIME
September 2, 2024
View Job Description
UCB
Medical Science Liaison (MSL) Rheumatology Netherlands
Breda
August 29, 2024
View Job Description
Stryker
Account Manager - Maxillofacial, ENT, and Medical Instruments
Almere
August 20, 2024
View Job Description
SyncVR Medical B.V. / GmbH / ApS / Ltd.
Medical Sales Representative NL
Utrecht
August 4, 2024
View Job DescriptionTrials24
Freelance Medical Customer Service Representative – Netherlands
FULL TIME
August 27, 2024
View Job DescriptionSee What’s New: Santen Job Opportunities
Santen
[The Netherlands] Manager, Supplier Quality Assurance
Amsterdam
FULL TIME
September 2, 2024
View Job Description
Santen
[The Netherlands] Manager, Supplier Quality Assurance
Amsterdam
FULL TIME
September 2, 2024
View Job DescriptionNew Job Alerts
Lab Digital
DevOps Cloud Engineer (Azure)
Utrecht
FULL TIME & PART TIME
September 23, 2024
View Job Description
JD Sports Netherlands
Payroll Specialist (m/f/d) Parttime
Amsterdam
PART TIME
September 23, 2024
View Job Description
Maastricht University
PhD Candidate: Harnessing heterosis in Pea (Pisum sativum) for sustainable, alternative protein
Venlo
FULL TIME
September 23, 2024
View Job Description
Vrije Universiteit Amsterdam
Postdoc position in Fungal Ecology & Fungal Biology
FULL TIME
September 23, 2024
View Job DescriptionVertico
Business Development Manager
Eindhoven
FULL TIME & CONTRACT
September 23, 2024
View Job Description
Maastricht University
PhD candidate at the Instituut MERLN
Maastricht
FULL TIME
September 23, 2024
View Job Description
Michael Page
(Sr.) Recruitment Consultant - MichaelPage Tilburg
Tilburg
September 23, 2024
View Job Description
Page Personnel
(Sr.) Recruitment Consultant - PagePersonnel Utrecht
Utrecht
September 23, 2024
View Job Description
CBOE
Senior Legal Counsel (12 Month FTC - Maternity Cover)
FULL TIME
September 23, 2024
View Job Description