Principal Device Technical Regulatory Specialist

McDermott Laboratories Limited

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.

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, including 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 aligned with overall program level timelines
• Drive the authoring and review of documents for regulatory submissions (e.g., NDA, ANDA, BLA, MAAs, variations) and related activities (meeting requests, planning, and execution)
• Ensure timely feedback to GDD Management and DPT on the outcomes of meetings or 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, including medical device classification and due diligence assessments

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 and strategic planning including 21 CFR 820 and MDR (EU) 2017/745
• Knowledge of global Medical Device and Drug-Device Combination Product quality requirements including ISO 13485 and 21 CFR 820.30
• Experience in multi-disciplinary teams within a pharmaceutical development environment with a focus on drug delivery/device
• Experience in device development programs with a focus on regulatory strategy and content
• Track record of leading device program teams in solving technical regulatory issues; people management experience is an advantage
• Knowledge of impact of device manufacturing processes on device development
• Excellent communication skills, written and verbal
• Strong teamwork orientation and willingness to contribute beyond core expertise
• Proficiency in English (speaking, comprehension, reading, and writing)

At Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace. If your past experience doesn't align with every requirement, we still encourage you to apply.

Benefits at Viatris include competitive salaries and an inclusive environment with opportunities such as:

• Excellent career progression opportunities
• Work-life balance initiatives
• Bonus scheme
• Health insurance
• Pension

Diversity & Inclusion at Viatris At Viatris, diversity and inclusion are essential to our mission. The diversity we foster can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. For more information, please visit Viatris 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. To learn more, please visit Viatris Sustainability.

Viatris is an Equal Opportunity Employer.

• Mid-Senior level

• Full-time

• Engineering and Information Technology

• Pharmaceutical Manufacturing

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Dublin, County Dublin, Ireland