Regulatory Affairs Manager – Core Diagnostics (Porto)

About the role

The Regulatory Affairs Manager will act as the primary regulatory liaison for the manufacturing site in Porto, driving strategic and operational support to ensure successful product commercialization and ongoing compliance with global regulations.

Key responsibilities

• Serve as the main point of contact for regulatory affairs, advising site leadership and cross‑functional teams.
• Develop and execute regulatory strategies for new product launches, hardware/software modifications, and manufacturing changes.
• Assess regulatory impact of product, process, supplier, labeling and software changes and provide implementation recommendations.
• Lead lifecycle management activities, including registrations, submissions, notifications, amendments and assessments to maintain market access.
• Collaborate with R&D, Quality, Manufacturing, Supply Chain, Marketing and Commercial teams to embed regulatory requirements into product development.
• Coordinate collection of technical documentation, testing data and certifications required for submissions.
• Monitor emerging regulations, standards and industry trends, and drive necessary corrective actions.
• Maintain site‑level procedures and controls to ensure continuous regulatory compliance.

Required profile

• Bachelor’s degree in a scientific, engineering, regulatory or related discipline (or equivalent experience).
• Minimum 5 years of relevant experience, with 7+ years in regulatory affairs within a regulated industry.
• Proven ability to manage multiple regulatory projects, prioritize tasks and meet deadlines.

Required skills

What we offer

• Opportunity to influence global product launches and regulatory strategy.
• Collaborative environment with cross‑functional teams.
• Professional development in a leading diagnostics organization.