Lead regulatory initiatives across product development, manufacturing, and distribution.
Liaise with regulatory authorities and support global sales growth through new product registrations and ongoing regulatory maintenance.
Ensure our products and genetic services meet global regulatory requirements throughout the product lifecycle.
Collaborate closely with post-market surveillance team.

Hold a Bachelor’s or Master’s degree in biology, chemistry, physics, or equivalent or experience of regulatory affairs for ART.
Bring 2–5 years of experience in regulatory affairs, preferably within the IVD or medical device industry.
Possess strong knowledge of EU IVDR and/or ISO 15189 requirements.
Systematic and analytical, yet proactive and pragmatic in finding solutions within a dynamic environment.
Detail-oriented, decisive, and a true team player, who builds strong relationships.
Curious and passionate about regulatory affairs with a technical interest in genetic services.
Fluent in both Spanish and English.
RAC (Regulatory Affairs Certification) is a plus.
Experience with software-based IVDs or IEC 62304 is highly desirable.

Regulatory Affairs Specialist

Key skills