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 OverviewWe are seeking a senior Regulatory Affairs professional to join our Quality and Regulatory Affairs (QA/RA) Team. This role has a strong focus on MDSAP applications and approvals and plays a key part in leading regulatory activities across multiple global markets.
The successful candidate will act as a subject matter expert in regulatory affairs, taking ownership of complex regulatory projects and submissions, providing guidance to colleagues, and collaborating closely with internal and external stakeholders to ensure ongoing compliance with international medical device regulations.
Key Responsibilities- Perform, prepare, review, and approve regulatory documentation with a primary focus on MDSAP countries, in accordance with applicable international laws and regulations, including but not limited to MDD 93/42/EEC (and amendments), EU MDR, FDA (CDRH/CDER), and cGMP.
- Lead Regulatory Affairs activities for projects and submissions, including planning, coordination, oversight, and execution.
- Provide technical guidance, coordination, and coaching to less experienced team members and/or external consultants when required.
- Contribute to the development, implementation, and continuous improvement of Regulatory Affairs methods, tools, and structures to organise regulatory and product/process information (e.g. EU Technical Documentation, US 510(k) files, Device x Country Release tables).
- Track and control regulatory submissions; review and advise on compliance with regulatory filings; research regulatory requirements; and provide clear regulatory guidance to internal stakeholders, with a primary focus on MDSAP markets.
- Assess product, process, and design changes for potential impact on existing regulatory approvals and submissions.
- Review marketing materials, labelling, and promotional content to ensure compliance with applicable regulatory requirements.
- Act as a key regulatory contact for internal teams, auditors, notified bodies, consultants, and regulatory authorities.
- Support audits and inspections and contribute to regulatory strategy discussions.
- Act as a coach or mentor for team members, as assigned.
- May serve as interim or back-up PRRC (Person Responsible for Regulatory Compliance) in the absence of the RA Director and perform PRRC-related duties if delegated.
- Bachelor of Science (BSc) or equivalent qualification, with a minimum of 7 years of relevant professional experience.
- Significant experience in regulatory affairs for high-risk medical devices.
- Proven experience with CE marking approvals and FDA 510(k) clearance processes.
- Extensive knowledge of MDD (Annex II), EU MDR, FDA/QSR, ISO standards, and ISO 13485:2016.
- Experience working directly with regulatory authorities, including Notified Bodies, FDA, Competent Authorities, and other global health authorities.
- Experience working in an international or matrixed environment is highly desirable.
- Strong knowledge of global medical device regulatory frameworks, including EU MDR, MDD, FDA/QSR, MDSAP, and ISO standards.
- Proven ability to manage regulatory submissions, approvals, and product lifecycle activities across multiple markets.
- Experience leading regulatory activities for projects and coordinating inputs from cross-functional teams and external partners.
- Ability to critically review technical documentation, labelling, and marketing materials for regulatory compliance.
- Ability to work independently, prioritise effectively, and manage multiple regulatory activities in parallel.
- Communication
- Adaptability
- Teamwork
- Problem Solving
- Accountability
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.
#J-18808-Ljbffr€70000 - €90000 monthly