RA Officer

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.