Regulatory Affairs Specialist

Oxford Global Resources; Longford; Vor Ort; EUR 60.000 - 90.000; Vollzeit

Zusammenfassung

Oxford Global Resources in Longford, Ireland seeks an experienced Regulatory Affairs Specialist to provide maternity leave cover within its Regulatory Affairs team. The role supports regulatory compliance, technical documentation, and ongoing product lifecycle activities.

The candidate will manage CE marking technical files, support international registrations, and assist with post-market surveillance, labeling, and inspections, working with QA, Medical Affairs, and cross-functional teams.

Qualifikationen

• Bachelor's degree or higher in Life Sciences, Biomedical Science, Chemistry or Biotechnology.
• 5+ years' regulatory affairs experience preferred; minimum 3 years.
• Strong preference for IVD experience and EU IVDR knowledge.
• Candidates with medical device regulatory experience (EU MDR) will be considered.
• Experience preparing and maintaining technical files and supporting CE marking.
• Experience with post-market surveillance, labeling and regulatory inspections desirable.

Aufgaben

• Prepare, maintain and lifecycle manage regulatory technical files for CE marking.
• Support technical documentation for international registrations.
• Support post-market surveillance regulatory activities.
• Review labeling and IFUs for regulatory compliance.
• Assist regulatory audits and inspections, including notified body reviews.
• Collaborate with QA, Medical Affairs, Supply Chain, Demand Planning and Commercial.

Kenntnisse

Regulatory affairs

CE marking

Post-market surveillance

Labelling compliance

IFUs

Cross-functional collaboration

Notified body audits

Ausbildung

Bachelor's degree in Life Sciences

Jobbeschreibung

Client in Longford is seeking an experienced Regulatory Affairs Specialist to provide maternity leave cover within its Regulatory Affairs team. The successful candidate will support regulatory compliance, technical documentation and ongoing product lifecycle activities.

Key Responsibilities

• Preparation, maintenance and lifecycle management of regulatory technical files, primarily supporting CE marking requirements.
• Support additional technical documentation for international product registrations.
• Support regulatory activities arising from post-market surveillance.
• Review product labelling and Instructions for Use (IFUs) for regulatory compliance.
• Support regulatory audits and inspections, including notified body reviews.
• Collaborate with cross-functional teams including Quality Assurance, Medical Affairs, Supply Chain, Demand Planning and Commercial.
• Manage multiple competing priorities in a busy regulatory environment.

Experience & Qualifications

• Bachelor's degree or higher in a relevant discipline, such as Life Sciences, Biomedical Science, Chemistry or Biotechnology.
• 5+ years' relevant Regulatory Affairs experience preferred; minimum 3 years.
• Strong preference for IVD experience and knowledge of EU IVDR.
• Candidates with medical device regulatory experience (EU MDR) will also be considered.
• Experience preparing and maintaining technical files and supporting CE marking.
• Experience with post-market surveillance, labelling and regulatory inspections desirable.