Quality & Regulatory Director Medical Device jobs

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.

The Role

We're looking for a Director, Device User Interface to lead a high-performing team translating user needs and use-related risks into robust, traceable design inputs across the device development lifecycle. You'll guide end-to-end Human Factors activities — from early formative evaluations through Summative and Comparative Use HF studies — and champion continuous improvement in UI processes, tools, and governance.

What You'll Be Doing

• Mentors and develops a high performing Human Factors (User Interface) team in the demonstration of safe and effective use of devices and drug delivery systems through the execution of usability engineering programs, ensuring methodological rigor, compliance and stakeholder acceptability.

• Fosters a culture of innovation, collaboration, and continuous improvement to execute the User Interface strategy for medical devices and drug-device combination products, aligned with regulatory labelling strategy, and ensuring intuitive design, accessibility, and patient-centric usability.

• Ensures right first time, inspection-ready User Interface deliverables.

• Maintains close partnerships with relevant global business owners through collaborative engagement with key stakeholders and establishing advocates in stakeholder teams.

• Oversees external vendors and study execution, ensuring methodological rigor, compliance, and timely delivery of Human Factors evidence.

About You

• Degree in Pharmaceutical Science, Medical Device/Product Design, or equivalent.

• Extensive experience in Pharmaceutical Development, Human Factors Engineering, or Medical Device/Combination Product Engineering, including several years in a leadership role.

• Proven track record leading development strategy and program execution.

• Knowledge of drug delivery technologies — e.g. pen injectors, autoinjectors, vial kits, inhaler technologies, and prefilled syringes.

• Detailed knowledge of key industry standards, including EU MDR, ISO 13485, ISO 14971, ISO 62366, and 21 CFR Part 820.

MSc, PhD, or MBA, and experience with both NCE and Generic product development are a plus.

At Viatris, we're building a truly diverse, inclusive, and authentic workplace. If you're excited about this role but your experience doesn't fully align with every requirement, we still encourage you to apply.

Benefits at Viatris

• Excellent career progression opportunities

• Work-life balance initiatives

• Bonus scheme

• Health insurance

• Pension

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.