Device Risk Management Specialist – MedTech Compliance Leader

1100 Mylan Pharmaceuticals Inc.; Dublin; On-site; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Career progression opportunities

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Diversity & Inclusion at Viatris

Job summary

Viatris is seeking a Risk Management Specialist to identify, assess and mitigate product risks across the development lifecycle, ensuring regulatory compliance and successful submissions.

You will lead risk activities for medical devices and combination products, develop ISO 14971–aligned documentation, and collaborate with cross‑functional teams to ensure safety, effectiveness and manufacturability.

Qualifications

• Bachelor's degree in engineering or life sciences.
• Experience in regulated industries (medical devices, pharmaceuticals).
• Knowledge of ISO 14971 and IEC 62366 is a plus.

Responsibilities

• Lead and support risk management activities across product development.
• Develop and maintain risk management docs per ISO 14971 and design controls.
• Collaborate with Device Development, Clinical, Pharmacovigilance, Quality, and Regulatory.
• Act as Risk Management SME for design reviews and regulatory submissions.
• Identify, assess, mitigate product risks in design, manufacturing, usability, and clinical use.
• Monitor risk data from design outputs, usability studies, and post-market feedback.
• Support change control and integrate risk considerations into processes.
• Drive continuous improvement of Risk Management and QMS.

Skills

Risk management

Regulatory submissions

Design Controls

QMS

Cross-functional collaboration

Education

Bachelor's degree in Engineering/Biomedical Engineering/Life Sciences

Job description

Viatris is seeking a Risk Management Specialist to identify, assess and mitigate product risks across the development lifecycle, ensuring regulatory compliance and successful submissions.

You will lead risk activities for medical devices and combination products, develop ISO 14971–aligned documentation, and collaborate with cross‑functional teams to ensure safety, effectiveness and manufacturability.