Hybrid Regulatory Affairs Specialist - IVD/EU MDR Expert

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

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.