McDermott Laboratories Limited
At VIATRIS, we see healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.
Viatris empowers people worldwide to live healthier at every stage of life.
We do so via:
Access – Providing high quality trusted medicines regardless of geography or circumstance;
Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
Partnership – Leveraging our collective expertise to connect people to products and services.
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
Global leadership of development, regulatory approval, commercialisation and lifecycle management of Viatris’s Medical Device (MD) and Combination Product (CP) business.
Every day, we rise to the challenge to make a difference and here’s how the Global Head of Device Development & Operations role will make an impact:
- Leadership of Viatris’s device and combination product operations throughout the product lifecycle.
- Leading device development, commercialisation, lifecycle management and operations encompassing design, tooling & equipment design & industrialisation, human factors usability, engineering performance, verification, risk management, device quality assurance, supplier management, technical regulatory, technical operations and portfolio management.
- Lead company device and related regulatory business strategy and continuous improvement to the operational delivery of high performing teams.
- Leadership of a sustainable, high-performing, multi-functional team that delivers to the global business need.
- Accountable for assuring implementation of device technical and operational activities at each commercial site / vertical related to device manufacturing, testing and supplies and ensure alignment with site commercial operations needs and schedules.
- Accountable to lead and drive compliance to local device regulations / legal compliance requirements, with all partners, sites and affiliates.
- Accountable to define regulatory requirements and regulatory strategy to development teams to ensure readiness for MD / CP approvals.
- Responsible for company Notified Body strategy (e.g. selection of NBs for different device technology and/or therapeutic areas) that enables cross-European market launches and post-launch maintenance.
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:
- Degree in science or engineering, or equivalent.
- Significant experience in a Leadership role within the Pharmaceutical Industry, working at a level where leadership and influencing skills have been consistently applied.
- Proven record in people management and organisational development.
- Excellent working knowledge of quality and regulatory standards, requirements and guidance’s within the device and combination product field in global markets; knowledge of US, EU, Canada and Australia a must-have.
- Experience in leading regulatory strategy and co-ordinating activities with regulatory bodies to support regulatory submissions.
- Ability to respond quickly to a changing business environment, with an ability to seek out knowledge and information quickly to make technical and prioritisation decisions when needed.
- Experience of working in a leadership capacity with external partners (project providers / CROs / CMOs / licensees).
- Knowledge of the impact of industrialisation and scale-up of device manufacturing processes in device development.
- Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the organization
- Excellent communication skills, accuracy and attention to detail
- Willingness to travel globally on an as-needs basis.
At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.
Why 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. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.
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.
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Viatris Dublin, Dublin, IRL Office
Dublin, Dublin, Ireland
