3 beste vacatures voor de functie van qa officer in nieuwegein, ut (nieuwe medewerkers gezocht)

RA Officer
Kuros Biosciences —Bilthoven
- € 4.600 - € 5.200 per maand
- Fulltime
- Projectmanagement
- Bachelor
- Communicatieve vaardigheden
Snel solliciteren
8 dagen
QA Officer
Aurobindo Pharma B.V. —Baarn
- Parttime
- Engels
- Master
- Analytisch vermogen
- Reiskostenvergoeding
- Werk vanuit huis
Snel solliciteren
1 dag
QA/QC Officer
Vergeer Holland —Reeuwijk
- € 3.457,00 - € 4.506,67 per maand
- Parttime
- ERP systemen
- Analytisch vermogen
- Computervaardigheden

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Senior adviseur - Onderwijskwaliteit & schoolontwikkeling
SvRK —Utrecht
Kennis van actuele ontwikkelingen zoals inclusief onderwijs, kansengelijkheid en de ontwikkeling van professionele kwaliteitsculturen;
Vanaf € 6.250 per maand
Snel solliciteren
Kwaliteitscoördinator (Product- & Brandveiligheid) (32 - 40 uur)
TABS Holland N.V. —Bunnik
Je bent nauwkeurig en kwaliteitsgericht, maar ook praktisch ingesteld en schakelt makkelijk met verschillende interne en externe stakeholders.
€ 3.400 - € 4.000 per maand

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RA Officer

Kuros Biosciences -
Bilthoven

Snel solliciteren

Vacaturegegevens

Fulltime
€ 4.600 - € 5.200 per maand
8 dagen geleden

Kwalificaties

Projectmanagement
Bachelor
Communicatieve vaardigheden

Volledige vacaturetekst

About Kuros Biosciences

Kuros Biosciences is a Swiss-listed life science company specializing in orthobiologics for spinal fusion surgery. With locations in Switzerland, the USA, and the Netherlands, we manufacture our bone repair products in Bilthoven and sell them worldwide. We are seeking an experienced RA Officer to join our growing team in Bilthoven.

Position Overview

We are seeking an experienced Regulatory Affairs Officer to join our Quality & Regulatory Affairs team at Kuros biosciences, with a primary focus on Rest of World (RoW) regulatory activities (excluding MDSAP). This role supports global regulatory submissions, approvals, and ongoing compliance for high-risk medical devices.

Member of the Quality and Regulatory Affairs (QA/RA) team
Primary focus on regulatory applications and approvals in RoW countries
Lead Regulatory Affairs responsibilities for assigned projects and country-specific submissions
Collaborate with internal and external stakeholders, including auditors, notified bodies, consultants, and health authorities

Key Responsibilities

Prepare, review, and manage regulatory submissions and documentation for RoW countries in compliance with international regulations
Track and control regulatory submissions and approvals
Research regulatory requirements and provide guidance to internal stakeholders
Review product changes for regulatory impact with a RoW focus
Review labeling and marketing materials for regulatory compliance
Support the setup of new territories (e.g. appointing distributors and RA agents)
Coordinate, review, or coach work performed by junior team members or external consultants when required
Lead RA activities within projects; final regulatory decisions remain with the Director of Regulatory Affairs
Act as a coach or mentor to team members when assigned

Qualifications and Experience

BSc or equivalent, with a minimum of 5 years of relevant Regulatory Affairs experience
Significant experience in regulatory affairs for high-risk medical devices
Experience with CE marking approvals
Experience with worldwide registrations
Strong knowledge of MDD (Annex II), MDR, ISO standards, and ISO 13485:2016
Experience working with Notified Bodies, Competent Authorities, and global Health Authorities
Residence in the Netherlands

Skills and Competencies

Strong project management, collaboration, and communication skills
Results-driven, persuasive, and decisive approach to ensuring compliance
Ability to work independently and effectively within multidisciplinary teams

Key Competencies

Communication
Adaptability
Teamwork
Problem solving
Accountability

Why Kuros Biosciences?

Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.

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qa officer vacatures in nieuwegein, ut

RA Officer

QA Officer

QA/QC Officer

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