Regulatory Affairs Specialist

Project overview

Are you an experienced Regulatory Affairs professional looking for a new challenge within the life sciences' industry? Have you proven technical expertise in IVD, ED IVDR and EU MDR? Are you ready to challenge yourself in a highly-regulated and fast-paced industry? You could be the perfect candidate for this opportunity! Don't hesitate, apply today!

Job Description

Our client 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.

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.

Requirements

• 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.

Project details

Longford, Ireland | hybrid

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• Start: flexible
• Location: Longford, Ireland, IE

Source notes

• Competitive and attractive employee compensation package
• Pension contributions
• Health insurance
• Paid public holidays.