RA Officer
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Job Location:
De Bilt - Netherlands
Monthly Salary:
€ 4900 - 5200
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
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 Buyer 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
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 youll 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.
Required Experience:
Senior IC
Key Skills
- CCTV
- Federal Agencies
- Customer Service
- Clearance
- Facility
- Suspicious Activity
- Property Damage
- Public Safety
- Daily Operations
- Professional Development
- Access Control
- Communication
- General Public
- Procedures
- Powerpoint
About Company
Kuros Biosciences is on a mission to discover, develop and deliver innovative fusion technologies that prevent non-unions.
