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 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.
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 ***** 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