Device Development Assurance Scientist

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

McDermott Laboratories Limited Viatris is a global healthcare company uniquely positioned to bridge the traditional divide between generics and brands, combining the best of both to more holistically address healthcare needs globally. With a mission to empower people worldwide to live healthier at every stage of life, we provide access at scale, currently supplying high-quality medicines to approximately 1 billion patients around the world annually and touching all of life's moments, from birth to the end of life, acute conditions to chronic diseases. We have been included on number of award lists that demonstrate the impact we are making. Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment. For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.

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.

• 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

• 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.

Benefits at Viatris

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension
• Diversity & Inclusion at Viatris

Diversity & Inclusion at Viatris

At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit https://www.viatris.com/en/Careers/Diversity-and-Inclusion

Sustainability at Viatris

Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visit https://www.viatris.com/en/about-us/corporate-responsibility

At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others.

Viatris is an Equal Opportunity Employer.

Viatris is a global healthcare company formed in 2020 through the combination of Mylan and Upjohn, a legacy division of Pfizer. By integrating the strengths of these two companies, including our global workforce, we aim to deliver increased access to affordable, quality medicines for patients worldwide, regardless of geography or circumstance. We believe in healthcare as it should be - empowering people worldwide to live healthier at every stage of life. Because of our unwavering belief that better access leads to better health, we leverage our best-in-class manufacturing and scientific expertise and proven commercial capabilities to bring quality medicines to patients when and where they need them.