Reg Affairs Manager
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Job Location:
Monthly Salary:
Posted on:
22 hours ago
Vacancies:
1 Vacancy
Job Summary
Job description
Pale Blue Dot Recruitment Irelands 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 companys 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.
Job 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 youre a proactive leader ready to make an impact apply now.
Pale Blue Dot Recruitment Experts in STEM Workforce Solutions
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Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
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