Principal Device Technical Regulatory Specialist

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

Our Global Device Development organisation is focused on the design, development, and commercialisation of a diverse portfolio of device technology solutions to enable delivery for our large and growing generic and branded products around the globe. We develop device technologies to enable drug-delivery for respiratory, biologic, and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from four sites: Dublin, Ireland, Cambridge and Sandwich, UK and Southpointe, Pittsburgh, USA. Every member of our team is dedicated to creating better health for a better world, one person at a time.

Every day, we rise to the challenge to make a difference and here’s how the Principal Device Technical Regulatory Specialist role will make an impact:

Subject Matter Expert (SME) in the application of FDA, EU and ISO standards, regulations and guidance related to design control and regulatory compliance:

• Maintain detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to Viatris development programs.

• Actively collaborate within both the Technical Regulatory function and wider GDD on the development of regulatory strategies for combination products and medical devices.

• Lead project teams in their awareness of current regulatory best practice when building device development plans.

• Provide mentoring for, and support the development of, the Technical Regulatory team.

• Provision of expert advice to the EU regulatory function in relation to the device constituent of Drug Device Combination products in accordance with the Medical Device Regulation (MDR) and associated European Medicines Agency (EMA) guidance’s. This includes but is not limited to assessment and remediation of on-market products to ensure compliance to current requirements and practices.

Lead the program team in the implementation and execution of strategies and plans that ensure compliance to regulations, legislations, standards, and regulatory guidelines:

• Collaborate within program teams to ensure regulatory strategies are disseminated and understood and aligned with the key milestones and critical path activities of the program.

• Collaborate within Device Program Teams (DPTs) to generate regulatory plans (e.g., meeting requests, submissions etc.) which are aligned with the overall program level timelines.

• Drive the authoring and review of documents for regulatory submissions; including, but not limited to, New Drug Applications (NDA), Abbreviated New Drug Applications (ANDA), Biologics License Application (BLA), Marketing Authorisation Applications (MAAs), variations and other related activities (e.g., meeting requests, planning, and execution).

• Ensure timely feedback to GDD Management and DPT on the outcomes of meeting / agency feedback with consideration to program and portfolio level consequences.

• SME for Software as a Medical Device (SaMD) for all global markets in support of the Global IT compliance function. This includes but is not limited to completion of medical device classification and due diligence assessments for all Global markets.

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 a scientific/engineering discipline. A master’s or higher degree desirable.

• Proven experience in pharmaceutical and/or medical device development’

• Advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements regulatory plans and high-level strategy planning including but not limited to 21 CFR 820 and MDR (EU) 2017/745.

• Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including but not limited to device design controls in accordance with ISO 13485 and 21 CFR 820.30.

• Demonstrable experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.

• Experience, at a team level, in device development programs, specifically with a focus on the preparation and delivery of technical regulatory strategy and content.

• Demonstrable track record of competence in leading device program teams in problem solving approaches to technical regulatory issues. People management experience a distinct advantage.

• Knowledge of the impact of device manufacturing processes in device development

• Excellent communicator; clear and concise in communications, both written and verbal.

• 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.