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
Every day, we rise to the challenge to make a difference and here’s how the Device Technical Regulatory Associate Specialist role will make an impact:
Support the planning, implementation, execution of
Medical device and combination product portfolio management.
Medical device and combination product regulatory intelligence gathering and dissemination including, but not limited to, regulatory guidance, policy, standards and laws governing medical devices (e.g. codified and in force regulations).
Regulatory compliance in accordance with the European Medical Device Regulation (EU) 2017/745 for Drug-Device Combination Products within the Global Device Development organization.
Support Global Device Development objectives for European regulatory agency/authority/Notified Body engagements and submission activities including, but not limited to: Meeting Requests, Notified Body Opinion submissions (NBOp), Marketing Authorisation Applications (MAAs) and variations.
As required support other global Technical Regulatory objectives related, but not limited to, US FDA New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologic License Applications (BLA) and related activities (e.g. meeting requests, planning and execution).
Ensure Quality Systems requirements supporting regulatory compliance are maintained.
Supports Device Technical Regulatory objectives within the Global Device Development organization related to
The design, development and commercialisation of Drug-Device Combination Products.
On-market Drug-Device Combination Products.
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:
Experience in the Medical Device and or Drug-Device Combination Product industry a distinct advantage.
Bachelor’s degree in a scientific/engineering discipline. A Masters or higher degree desirable.
Knowledge of Pharmaceutical and/or Medical Device development, with Drug-Device Combination Product or drug delivery/device experience a distinct advantage.
Knowledge of European regulatory requirements for Combination Products and Medical Devices (Medical Device Regulation (EU) 2017/745, Medical Device Directive 93/42/EEC and Medicinal Products Directive 2001/83/EC). Knowledge of United States and other jurisdictional regulatory requirements a distinct advantage.
Experience with Drug-Device Combination Product Marketing Authorisation Applications and/or Medical Device CE marking applications. Experience with eCTD and/or device technical files a distinct advantage.
Excellent communicator; clear and concise in communications.
Effective presentation skills, both written and verbal.
Ability to work flexibly across a multi-disciplinary team in jointly achieving departmental goals.
Strong team player that is willing to take on and support other activities outside core expertise as required to develop the future of the department.
Proficiency in speaking, comprehending, reading and writing English is required.
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.
