Regulatory Affairs Manager

Pale Blue Dot® Recruitment – Ireland’s go-to STEM talent partner – is recruiting on behalf of an innovative IVD manufacturer seeking a Regulatory Manager to lead their regulatory function and ensure ongoing compliance across global markets.

This is a senior-level opportunity for an experienced regulatory professional who thrives in a fast-paced, quality-driven environment. Reporting to the Chief Operations Officer, you will lead a high-performing regulatory team and manage global compliance strategies to support the company’s current and future product portfolio.

Key Responsibilities include but are not limited to:

• Lead, coach, and develop a team of regulatory professionals to deliver results.
• Oversee implementation of regulatory strategies in line with evolving requirements.
• Manage and maintain technical documentation for Class A and B IVD products.
• Drive post-market surveillance and risk management processes.
• Coordinate vigilance reporting for CE-IVD and other international markets.
• Maintain and expand regulatory certifications in existing and new territories.
• Collaborate cross-functionally with R&D, Manufacturing, and Quality on compliance and product strategies.
• Stay current on international regulatory requirements (EU IVDR, MDR, etc.) and communicate implications company-wide.
• Act as Deputy Person Responsible for Regulatory Compliance (PRRC), when needed.

• BSc in Molecular Biology or related scientific discipline.
• Minimum 5 years\' regulatory experience within the Medical Device or IVD sector.
• At least 2 years\' experience leading or supervising regulatory personnel.
• Expert knowledge of ISO 13485 and EU IVDR/MDR.
• Strong documentation, organisational and interpersonal skills.
• Ability to manage multiple projects and competing priorities with precision.
• Experience with Software as a Medical Device (SaMD) and associated standards.
• Proven experience liaising with Notified Bodies or international Regulatory Authorities. xcfaprz

This is a rare opportunity to join a dynamic, forward-thinking company at the forefront of diagnostic innovation. If you're a proactive leader ready to make an impact, apply now.

Pale Blue Dot® Recruitment – Experts in STEM Workforce Solutions