Regulatory Affairs Specialist

Hero Recruitment; Limerick; On-site; EUR 65,000 - 90,000; Full time

Job summary

Hero Recruitment is seeking a Regulatory Specialist for a full-time, permanent role reporting to the Regulatory Manager. You will help ensure all regulatory requirements are current across departments and support premarket submissions.

Responsibilities include maintaining technical documentation, handling regulatory reporting for CE-IVD products, and supporting audits. Collaborate with Quality and R&D to align regulatory activities with product milestones and market needs.

Qualifications

• BSc in Molecular Biology or related discipline.
• Minimum 3 years in regulatory role for Medical Device or IVD.
• Experience reviewing and approving technical documentation per EU/US regulations.
• Knowledge of ISO 13485, ISO 14791 and IVDR/MDR.
• Ability to manage competing priorities in a fast-paced environment.
• Strong writing, verbal and interpersonal skills.

Responsibilities

• Assist in preparing and submitting premarket regulatory documentation (EU IVDR, 510(k)) and other international filings.
• Review, maintain and approve technical documentation in compliance with regulations.
• Review complaints, CAPAs and non-conformances for regulatory reporting.
• Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance files.
• Review artwork and labels for regulatory compliance.
• Review change controls for impact on regulatory compliance.
• Monitor changes in legislation, standards and guidance documents and communicate findings to cross-functional teams.
• Assist in distribution processes to ensure regulatory compliance.
• Support regulatory audits and inspections and maintain regulatory records.
• Collaborate with Quality and R&D to align regulatory activities with milestones.

Skills

Regulatory expertise

Written & verbal communication

Cross-functional collaboration

Prioritization under pressure

Education

BSc in Molecular Biology or related

Job description

Regulatory Specialist Full-time, permanent position - Reporting to the Regulatory Manager

We have a requirement for a Regulatory Specialist who will assist in ensuring all regulatory requirements are up to date in all departments.

Main Duties:

• Assist in the preparation, compilation and submission of premarket regulatory documentation, including EU IVDR submission, 510(k) submissions and other international filings, ensuring accuracy, completeness and adherence to regulatory requirements.
• Review, maintenance and approval of technical documentation of products, in compliance with the relevant regulations and standards.
• Review complaints, CAPAs and non-conformances for regulatory reporting for CE-IVD marked products.
• Assist in preparation, maintenance and approval of Risk Management and Post Market Surveillance Files
• Review and approval of artwork (labels, instructions for use) for compliance with applicable regulatory requirements and international standards.
• Review change controls for impact on regulatory compliance.
• Monitor changes in legislation, standards and guidance documents related to products and communicate findings to cross functional teams as required.
• Assist in distribution process to ensure regulatory compliance.
• Support regulatory audits and inspections.
• Maintain appropriate regulatory records.
• Review and approve internal and external queries and requests.
• Collaborate effectively with cross functional teams such as Quality and R&D to gather necessary information and align regulatory activities with product development milestones.

Essential Criteria:

• BSc in Molecular Biology or a relevant discipline.
• Minimum 3 years’ experience working in a regulatory role for a Medical Device or In Vitro Diagnostic Company.
• Experience in reviewing and approving technical documentation as per EU/US regulations.
• Good working knowledge of ISO 13485, ISO 14791 and IVDR/MDR.
• Ability to manage competing priorities in a fast-paced environment.
• Ability to work to tight deadlines
• Good initiative and team player
• Strong writing, verbal and interpersonal skills.

Desirable Criteria:

• Experience supporting product launches in new markets.
• Experience in audits or inspections.
• Experience in health authority interactions.