Regulatory Affairs Specialist - Oncology IVD

About the role

As a Regulatory Affairs Specialist in the Oncology In-vitro Diagnostics (IVD) team, you will partner with cross-functional internal teams and external stakeholders to bring diagnostic solutions to market. You will prepare high-impact submission dossiers for Health Authority approvals and champion agile principles to drive regulatory milestones.

Key responsibilities

• Lead and coordinate the preparation of registration dossiers for products and programs of moderate complexity, and formulate submission plans to secure global market access.
• Apply knowledge of global regulations such as IVDR, FDA and ISO 13485 to set up robust regulatory pathways that keep products compliant.
• Build collaborative relationships with internal partners and external regulatory bodies, and contribute to inspection and audit readiness, execution and corrective actions.
• Identify operational bottlenecks and propose practical solutions, and explore digital tools or automated workflows to improve efficiency.
• Act with the VACC leadership model (Visionary, Architect, Catalyst, Coach) and foster an inclusive, high-trust team.

Required profile

• University degree (Bachelor's or Master's) in Life Sciences, Biotechnology, Biomedical Engineering, Data Science or a related field, or equivalent practical experience.
• More than 1 year of relevant experience in Regulatory Affairs, Quality Assurance, R&D or Clinical Operations in healthcare or life sciences.
• Fluency in English, written and spoken, able to explain regulatory concepts across diverse teams.
• Willingness to pursue development across functions and geographies.

Required skills

• Proficiency in MS Office and Electronic Document Management Systems (EDMS/RIMS).
• Nice to have: hands-on experience with IVD or medical device regulations (EU IVDR, US FDA 510(k)/PMA), exposure to RPA or AI-enabled regulatory tools, and familiarity with ISO 13485.