20 beste vacatures voor de functie van procesoperator in 2291 wateringen (nieuwe medewerkers gezocht)

Manager, Regulatory Affairs EMEA
Thermo Fisher Scientific —Bleiswijk
- Fulltime
- Engels
- Projectmanagement
- Bachelor
Operations & Maintenance Technician
Shell —Maasvlakte
- Fulltime
- Engels
- Flexibele werkuren
Associate III Manufacturing, Cell Therapy
Bristol-Myers Squibb —Leiden
- Fulltime
- Hybride werken
- Microsoft Word
- Microsoft Excel
- Management
AUT - Operator NL
Applus+ —Rotterdam
- € 3.000 - € 4.600 per maand
- Online sollicitatie
- Microsoft Office
- Communicatieve vaardigheden
Snel solliciteren
Procesoperator Schiedam
Boskalis —Schiedam
- € 3.400 - € 4.400 per maand
Procesoperator 5-ploegen
AVR afvalverwerking b.v. —Rozenburg
- Tot € 5.109 per maand
- Fulltime
- Reiskostenvergoeding
- Zorgverzekering
Snel solliciteren
Cleanroom Logistics Operator
Nearfield Instruments —Rotterdam
- Fulltime
- Microsoft Excel
- ERP systemen
- Engels
Operator reachtruck/heftruck (Transport company)
charcoco b.v. —Bleiswijk
- € 2.750 - € 3.270 per maand
- Overwerk
- Microsoft Outlook
- Assemblage
- Magazijn
- Reiskostenvergoeding
Snel solliciteren
FPV Drone Operator, Videographer & Photographer
Destinus —Katwijk aan Zee
- Fulltime
- Hybride werken
Snel solliciteren
Leerling Operator bij de Defensie Pijpleiding Organisatie (DPO)!
Ministerie van Defensie —Poortugaal
- € 2.976 - € 3.592 per maand
- Fulltime
Procesoperator / Operator | Tot € 3.800 | Bleiswijk
YES Groep —Bleiswijk
- Tot € 3.800 per maand
- Online sollicitatie
- Reiskostenvergoeding
1 dag
Operations & Maintenance Technician
Shell Energy —Maasvlakte
- Fulltime
- Engels
- Flexibele werkuren
Leerling Mechanisch Operator B
Dunea —Scheveningen
- € 2.831 - € 3.783 per maand
- Parttime
Teamleader Inpak 5 ploegendienst
Farm Frites —Oudenhoorn
- € 4.698 - € 6.120 per maand
- Parttime
- Microsoft Office
- Productie
- Zorgverzekering
Snel solliciteren
Panel operator
Euroliquids —Rotterdam
- € 2.700 - € 3.500 per maand
- Parttime
- Productie
- Kosteloos parkeren
- Reiskostenvergoeding
Crawler Crane Operator – Global Projects
Mammoet —Schiedam
- Zwaar tillen
- Engels
- Communicatieve vaardigheden
Warehouse Operator / Storekeeper
Northrop Grumman Sperry Marine —Vlaardingen
- Computervaardigheden
- ERP systemen
- Heftruck
Continuous Improvement Coördinator
Euro-Caps —Rotterdam
- € 4.000 - € 5.000 per maand
- Parttime
- Data-analyse
- Analytisch vermogen
- Bachelor
Machine Operator (dagdiensten)
Rijk Zwaan —De Lier
- € 2.793 - € 3.821 per maand
- Fulltime
Commissioning Service Engineer - Hightech Verpakkingsmachines
Wolf Groep —Rotterdam
- € 3.550 - € 5.475 per maand
- Fulltime
- Engels
- Elektrotechniek
- Winstdeling
- Bedrijfsfitness

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van procesoperator in 2291 wateringen

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Manager, Regulatory Affairs EMEA

Thermo Fisher Scientific -
Bleiswijk

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Vacaturegegevens

Fulltime

Kwalificaties

Supplychain
Biomedische technologie
Engels
Projectmanagement
Bachelor
Veiligheid
Gegevensverzameling
Communicatieve vaardigheden

Volledige vacaturetekst

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of Thermo Fisher Scientific’s mission to enable our customers to make the world healthier, cleaner and safer, the Manager, Regulatory Affairs – EMEA is responsible for leading regulatory activities for the LSG IVD and/or MD medical device portfolio within the EMEA region.

This role ensures compliance with applicable EU regulations, including IVDR (EU 2017/746) and MDR (EU 2017/745, where applicable), and is accountable for EU product registrations, post-market surveillance (PMS), vigilance reporting, and Economic Operator compliance. The position partners cross-functionally to support product lifecycle management and sustainable market access across the EMEA region.

This is a site-based role with some flexibility according to our Global Policy - typically 1 day/week remote.

Key Responsibilities

Regulatory Strategy & Product Registration

Lead EU regulatory strategy and execution for LSG IVD and/or MD products.

Serve as the primary regulatory contact with EU Competent Authorities and/or Notified Bodies.

Support new product introductions and lifecycle changes to maintain EU market access.

Support EUDAMED registrations and UDI compliance as required

Monitor changes in EU regulatory requirements and assess their impact on the product portfolio.

Post-Market Surveillance (PMS)

Oversee and manage Post-Market Surveillance activities for IVD and/or MD products in accordance with IVDR/MDR requirements and/or applicable requirements.

Ensure PMS plans, reports (PMSR/PSUR), and trend analyses are developed and maintained appropriately.

Collaborate with Quality and Medical Affairs to ensure effective post-market data collection and evaluation.

Vigilance Reporting

Lead EU vigilance reporting activities, including serious incident reporting and Field Safety Corrective Actions (FSCA).

Ensure timely submission of reports to Competent Authorities and/or coordination with Notified Bodies.

Drive compliance with EU/MEA vigilance timelines and internal SOPs.

Economic Operators Compliance

Serve as the primary liaison between LSG and the EC Authorized Representative (EU AR), ensuring effective communication and regulatory alignment.

Act as the Person Responsible for Regulatory Compliance (PRRC) for the EU Authorized Representative.

Support compliance of Economic Operators (Manufacturer, Authorized Representative, Importer, Distributor) under IVDR/MDR requirements.

Provide guidance to internal and external stakeholders regarding EU regulatory obligations.

Cross-Functional Partnership & Compliance

Collaborate cross-functionally with Quality, Clinical, R&D, Supply Chain, and Commercial teams to ensure regulatory compliance throughout the product lifecycle.

Support all business units of LSG to comply with regulatory requirements of the IVDD/IVDR, MDD/MDR, national legislation in EU countries.

Support internal audits, external audits, and regulatory inspections.

Provide regulatory guidance and training to internal stakeholders as needed.

Monitor regulatory intelligence and assess impact of regulatory changes on the portfolio.

Recruits, coaches and develops organizational talent.

Qualifications & Requirements

Bachelor’s degree or above in Life Sciences, Biomedical Engineering, Pharmacy, or related field.

Minimum 8 years of experience preferred in Regulatory Affairs within the medical device and/or IVD industry.

Strong knowledge of EU IVDR (EU 2017/746) and MDR (EU 2017/745) regulations.

Demonstrated experience in EU product registration and lifecycle management.

Hands-on experience with Post-Market Surveillance and Vigilance reporting.

Strong project management skills with the ability to manage multiple priorities.

Excellent communication skills in English (written and verbal).

Ability to work independently and collaboratively in a cross-functional, global environment.

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization as well with external authorities.

Willingness to travel up to 30%.

Preferred Qualifications

Experience in managing regulatory teams and/or projects in a matrix organization.

Experience working with EU Competent Authorities and Notified Bodies is preferred.

Experience collaborating with cross-functional teams in a geographically diverse, matrixed organization.

Apply now!

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procesoperator vacatures in 2291 wateringen

Manager, Regulatory Affairs EMEA

Operations & Maintenance Technician

Associate III Manufacturing, Cell Therapy

AUT - Operator NL

Procesoperator Schiedam

Procesoperator 5-ploegen

Cleanroom Logistics Operator

Operator reachtruck/heftruck (Transport company)

FPV Drone Operator, Videographer & Photographer

Leerling Operator bij de Defensie Pijpleiding Organisatie (DPO)!

Procesoperator / Operator | Tot € 3.800 | Bleiswijk

Operations & Maintenance Technician

Leerling Mechanisch Operator B

Teamleader Inpak 5 ploegendienst

Panel operator

Crawler Crane Operator – Global Projects

Warehouse Operator / Storekeeper

Continuous Improvement Coördinator

Machine Operator (dagdiensten)

Commissioning Service Engineer - Hightech Verpakkingsmachines

Ik wil de nieuwste vacature-alerts ontvangen voor de functie van procesoperator in 2291 wateringen

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