The Position:

We are seeking an experienced and self-driven Regulatory Affairs Manager with a strong background in international registrations and regulatory intelligence of in vitro diagnostics (IVD). This role will play a key part in supporting the global expansion and lifecycle management of our IVD product portfolio which includes assay, software, and instrument components. The position will also contribute to the development of strategic regulatory processes and cross-functional initiatives aligned with international standards and regulations. This is an exciting opportunity to help shape global regulatory strategy and lifecycle support for cutting-edge diagnostic products that make a meaningful impact in healthcare

The ideal candidate thrives in a fast-paced, collaborative, and technically complex environment and is passionate about ensuring compliance and delivering safe and effective products to patients.

This role reports to the Senior Director of Global Regulatory Affairs (EU-based) and collaborates closely with the global Regulatory Affairs (RA) and Quality teams to ensure regulatory compliance and enable product registrations globally thereby assisting in expanding market access.

Key Responsibilities:

• Lead international regulatory submissions and registration strategies across key markets (e.g., EU, LATAM, APAC, Middle East, and Canada) for IVD products.
• Monitor, analyze, and communicate global regulatory intelligence, including updates to legislation, guidance documents, and emerging market trends, with actionable insights for internal stakeholders.
• Support IVD product development teams by providing regulatory guidance on requirements impacting new product introductions and changes to existing products.
• Collaborate in the preparation, review, and submission of technical documentation to meet IVDR, MDSAP, and other global regulatory requirements.
• Participate in and support internal and external audits, inspections, and regulatory authority interactions related to international registrations and regulatory intelligence activities.
• Assist in the development and implementation of regulatory policies and procedures to ensure effective global compliance and continuous improvement within the RA function.
• Represent Regulatory Affairs in cross-functional initiatives focused on product lifecycle management, regulatory readiness, and global market access strategies.
• Support internal and external training initiatives to increase organizational awareness of global registration requirements.
  
  

Who You Are:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• Minimum of 5 years of regulatory affairs experience in the IVD or medical device industry, with strong exposure to international regulatory submissions and post-market activities.
• Solid understanding of IVDR, ISO 13485, MDSAP, and other global regulatory frameworks.
• Proven experience managing global IVD registration programs, including interactions with competent authorities.
• Excellent communication, analytical, and project management skills.
• Self-motivated, adaptable, and capable of working independently in a remote, globally distributed team.
  
  

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