Regulatory Affairs Specialist

Oxford Global Resources; Longford; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Pension contributions

Health insurance

Paid public holidays

Job summary

Oxford Global Resources is seeking an experienced Regulatory Affairs Specialist to cover maternity leave in its life sciences regulatory team. The role focuses on regulatory compliance, technical documentation, and product lifecycle activities across global markets.

The ideal candidate will have 5+ years in Regulatory Affairs, strong IVD/EU IVDR knowledge, and proven experience with CE marking, labeling, post-market surveillance, and regulatory inspections.

Qualifications

• 5+ years in regulatory affairs preferred; minimum 3 years.
• Experience with IVD and EU IVDR is strongly preferred.
• Experience preparing and maintaining technical files and supporting CE marking.
• Experience with post-market surveillance.

Responsibilities

• Prepare, maintain and lifecycle manage regulatory technical files for CE marking.
• Support international product registrations with regulatory documentation.
• Contribute to post-market surveillance regulatory activities.
• Review labeling and IFUs for regulatory compliance.
• Assist with regulatory audits and notified body reviews.

Skills

Regulatory affairs

EU IVDR

EU MDR

Technical documentation

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

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!

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.

Benefits

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

Location

Longford, Ireland | hybrid

Desired Skills and Experience

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.