1484 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 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, biosimilar and injectable products, and work across Viatris to support innovative technology solutions to provide healthcare solutions for our patients. We operate from 4 sites: Dublin, Ireland, Cambridge & 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 Product Lifecycle Management Specialist role will make an impact:
Key responsibilities for this role include:
- Provide support to execution of activities in the product lifecycle management / post-marketing phase including but not limited to:
- Execution of searches of available on-line databases for information on complaints, vigilance events, adverse events, recalls and other available medical device and combination product safety related information and review and preparation of this data for inclusion in relevant product review reports.
- Execution of searches in company databases for complaints, change controls, CAPAs, Quality Incidents, Product Registrations and review and preparation of this data for inclusion in relevant product review reports.
- Recording, storage and trending of product complaint data received (weekly, quarterly and monthly)
- Coordination of collection of data from Viatris affiliates (APRs, Units Sold) to support Routine Program Review execution.
- Preparation of trending and analysis of complaints, CAPAs, QIs as requested.
- Liaising with Viatris affiliates in relation to life-cycle management processes, such as change controls, complaints support.
- Support the Integration of DHF / Technical Documentation to GDD through review and gap-analysis of documentation received, and upload into GDD Document Management Systems.
- Support the execution of updates to DHFs / Technical Documentation arising from product reviews.
- Support the identification of updates to Risk Management Files arising from product reviews / complaints trends.
- Support the general development and improvement of the GDD Quality System through participation in and/or management of CAPA, Internal Audit program, complaints, trending and training
- Support third party inspections/audits
The minimum qualifications for this role are:
- Third Level Qualification in Science, Engineering or Biotechnology or a combination of education and direct transferrable experience
- Minimum 3-5 years relevant professional experience
- Demonstrated ability to perform in a high performing workforce
- Demonstrated understanding of Quality System and regulatory requirements e.g. ISO13485, 21 CFR (EU)
- Demonstrated understanding of product life-cycle management / post-marketing requirements for medical devices and / or combination products.
- Demonstrated experience and understanding of Risk Management principles for Medical Devices / Combination products as per ISO 14971.
A t Viatris, we offer competitive salar ies , 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.