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/MDRoys
.
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.
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Pale Blue Dot® Recruitment – Experts in STEM Workforce Solutions
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