Pale Blue Dot Recruitment– Ireland's go-to STEM talent partner – is recruiting on behalf of an innovative IVD manufacturer seeking aRegulatory Managerto 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 incluce 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.Essential Requirements: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.Desirable:Experience with Software as a Medical Device (SaMD) and associated standards.Proven experience liaising with Notified Bodies or international Regulatory Authorities .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