Senior Device Risk & Compliance Engineer

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 90,000 - 130,000; Full time

Job summary

Viatris is expanding its Global Device Development team and seeks a Senior Risk Management Engineer/Scientist to lead RM processes for combination products and devices. You will collaborate with Quality, Clinical and Pharmacovigilance to ensure RMFs stay current, compliant and effective across the product lifecycle.

The role requires experience in ISO 14971:2019, FDA 21 CFR 820, and global RM practices, with a focus on cross-functional leadership and timely risk communications.

Qualifications

• Degree with proven direct experience in regulated Pharma/Medical Device/GMP environment.
• Ability to work independently and with cross-functional teams.
• Excellent communication to lead stakeholders and teams.

Responsibilities

• Lead RM process implementation for combination products/devices.
• Provide SME support across device lifecycle including regulatory submissions.
• Drive process improvements for high-quality program delivery.
• Develop RM principles, processes and procedures for up-to-date RM practices.
• Lead Device Program Teams in RMF deliverables (FMEA, FTA, hazard lists).
• Contribute to regulatory submissions, responses and audits.
• Assess RMFs against on-market data and update post-market activities.

Skills

Excellent communication

Independent worker

Problem solving

Education

Degree in regulated Pharma/Medical Device

Job description

Viatris is expanding its Global Device Development team and seeks a Senior Risk Management Engineer/Scientist to lead RM processes for combination products and devices. You will collaborate with Quality, Clinical and Pharmacovigilance to ensure RMFs stay current, compliant and effective across the product lifecycle.

The role requires experience in ISO 14971:2019, FDA 21 CFR 820, and global RM practices, with a focus on cross-functional leadership and timely risk communications.