Regulatory Affairs Specialist: Medical Devices

Fuze Health Inc.; Dublin; Remote; EUR 45,000 - 50,000; Full time

Benefits offered by this job

Health insurance

Pension

Annual compensation reviews

Referral bonus programme

Career clinics

Job summary

Fuze Health Inc. in Dublin seeks a Regulatory Affairs Specialist to support regulatory requirements across global jurisdictions for in vitro diagnostics and medical devices.

You will collaborate with clinical, quality, and engineering teams to prepare submissions, maintain EU IVDR/MDR files, and support post-market activities. The role emphasizes cross-functional teamwork, continuous improvement, and building relationships with regulatory authorities, consultants, and internal departments to

Qualifications

• 2-3 years of regulatory experience in the medical device or IVD industry.
• Experience assisting with the maintenance of EU technical files.
• Excellent written and oral communication skills, attention to detail, and the ability to handle multiple projects.
• Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options.

Responsibilities

• Act as a contributing Regulatory Team member for assigned regulatory projects.
• Creation and review of SOPs, change control forms, CAPA/NCR process.
• Support role to Quality team and in Internal/External Audits, particularly ISO 13485:2016.
• Support development and implementation of Regulatory Strategy and provide regulatory input to new product development.

Skills

Regulatory experience

MS Office

Communication skills

Detail-oriented

Time management

Education

Life sciences degree

Tools

MS Office

Job description

Fuze Health Inc. in Dublin seeks a Regulatory Affairs Specialist to support regulatory requirements across global jurisdictions for in vitro diagnostics and medical devices.

You will collaborate with clinical, quality, and engineering teams to prepare submissions, maintain EU IVDR/MDR files, and support post-market activities. The role emphasizes cross-functional teamwork, continuous improvement, and building relationships with regulatory authorities, consultants, and internal departments to