Device Development Assurance Scientist

Device Development Assurance Scientist

Viatris

Dublin, Ireland

The Role & What You Will Be Doing

As a Risk Management Specialist, you will play a critical role in identifying, assessing, and mitigating product risks throughout the development lifecycle, ensuring compliance with international standards and regulatory requirements while supporting successful product delivery and regulatory submissions.

Every day, we rise to the challenge to make a difference and here’s how the Device Development Assurance Scientist role will make an impact:

• 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 Subject Matter Expert (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.

About Your Skills & Experience

For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:

• 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, Quality Management Systems (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.