Medical Device Risk Lead & Assurance Scientist

Viatris; Dublin; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Excellent career progression

Work-life balance initiatives

Bonus scheme

Health insurance

Pension

Job summary

Viatris is seeking a Risk Management Specialist to lead risk activities across the medical device development lifecycle, ensuring regulatory compliance and design control adherence. The role partners with cross-functional teams to guarantee safe, effective, and manufacturable products.

Ideal candidates will have ISO 14971/IEC 62366 knowledge, QMS experience, and certifications in Lean or Six Sigma. This permanent role emphasizes collaboration, continuous improvement, and regulatory submissions

Qualifications

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, or a related technical discipline.
• Experience in a regulated industry (Medical Devices, Combination Products, Pharmaceuticals, Biotechnology, or Healthcare).
• Experience applying risk management principles within product development.
• Knowledge of Design Controls, QMS, and medical device/combination product regulatory requirements.
• Experience supporting regulatory submissions and combination product development would be an advantage.
• Knowledge of ISO 14971 and IEC 62366 would be an advantage.
• Relevant certification in Lean, Six Sigma, Quality Engineering, or Project Management would be an advantage

Responsibilities

• Lead and support Risk Management activities throughout the product development lifecycle for medical devices and combination products.
• Develop and maintain Risk Management documentation in compliance with ISO 14971, Design Control requirements, and global regulatory standards.
• Partner with cross-functional teams including Device Development, Clinical, Pharmacovigilance, Quality, and Regulatory Affairs to ensure products are safe, effective, and manufacturable.
• Act as the Risk Management SME, providing guidance throughout design and development activities, stage-gate reviews, and regulatory submissions.
• Identify, assess, mitigate, and communicate product risks related to design, manufacturing, usability, and clinical use.
• Monitor and evaluate risk-related data from design outputs, usability studies, and post-market feedback to inform product development decisions.
• Support change control assessments and ensure risk management considerations are incorporated into development and quality processes.
• Drive continuous improvement initiatives across Risk Management and Quality Management Systems.

Skills

Regulated industry experience

Risk management

Device development

Cross-functional collaboration

Education

Bachelor's degree in Engineering or Life Sciences

Tools

ISO 14971

IEC 62366

Quality Management Systems

Job description

Viatris is seeking a Risk Management Specialist to lead risk activities across the medical device development lifecycle, ensuring regulatory compliance and design control adherence. The role partners with cross-functional teams to guarantee safe, effective, and manufacturable products.

Ideal candidates will have ISO 14971/IEC 62366 knowledge, QMS experience, and certifications in Lean or Six Sigma. This permanent role emphasizes collaboration, continuous improvement, and regulatory submissions