Assistant Professional Regulatory Affairs- Medical Devices

Description Overview

We are excited to recruit a Regulatory Affairs Assistant within our Medical Device Lifecycle Management team. You will support Perrigo’s medical device portfolio throughout the product lifecycle, contributing to regulatory activities that help maintain product compliance, availability and market access across multiple markets. 

Working with cross-functional stakeholders including Quality, Safety, Supply Chain, Manufacturing, R&D and Regulatory Operations, you will provide regulatory support for product, labelling, process and documentation changes and assist in implementing regulatory requirements that support compliance and business needs. 

You will contribute to the continuous improvement of Regulatory Affairs processes, systems and ways of working, helping to improve efficiency, consistency and quality across medical device lifecycle activities. Through your role, you will develop foundational knowledge of medical device regulations and gain experience working within a global regulatory environment. 

This role offers an excellent opportunity to begin or further develop a career in Medical Device Regulatory Affairs, building technical expertise, regulatory knowledge and professional capabilities while supporting Perrigo’s commitment to maintaining high standards of compliance, consumer safety and product quality. 

Scope of the Role

• Supports the compliant maintenance of Perrigo’s medical device portfolio by contributing to lifecycle regulatory activities, documentation quality, and implementation tracking across products and markets. 
• Provides a pathway into Regulatory Affairs for either a graduate building foundational regulatory capability or an experienced administrator/coordinator moving into a regulatory career pathway. 
• Builds practical understanding of medical device regulatory delivery while operating with agility across changing priorities and supporting a flexible work remit in line with business needs. 
• Supports post-launch regulatory execution for medical devices under the direction of more experienced regulatory colleagues. 
• Works across change documentation, trackers, technical documentation updates and basic implementation support for defined products or workstreams. 
• Contributes within project teams with no people leadership and increasing exposure to product types, markets, and regulatory systems. 
• Lifecycle Delivery Support 
• Support preparation, compilation, and maintenance of medical device regulatory documentation, technical documentation, records, and trackers. 
• Assist with planning and tracking for post-market changes, notifications, registrations, renewals, and related maintenance activities. 
• Gather and organise source information required to support regulatory assessments, technical documentation updates, and implementation activities. 
• Contribute to accurate implementation tracking for approved changes to help protect compliance, product availability and continuity of supply. 
• Compliance, Documentation & Process Discipline 
• Maintain records and documentation in line with Good Documentation Practice and established regulatory and quality processes. 
• Support responses to routine internal or external regulatory queries, including notified body or competent authority information requests, under guidance. 
• Escalate uncertainties, gaps, or risks promptly and accurately. 
• Contribute to disciplined handover and transition of regulatory information, decisions, and files across interfaces. 
• Build understanding of medical device lifecycle processes, regulatory requirements, systems, and terminology across products and markets. 
• Work effectively with Medical Device Regulatory Affairs, Lifecycle Management, Category, Cluster, Quality, Safety, R&D, Supply, Artwork, and Regulatory Operations colleagues. 
• Demonstrate flexibility to support a range of administrative, coordination, and entry-level regulatory activities depending on business priorities. 

Experience Required

• Degree in Life Sciences or a related discipline, or relevant administrative/co-ordination experience in a regulated, quality-driven, or document-intensive environment. 
• This role is suitable for candidates with up to 2 years’ Regulatory Affairs experience, preferably within medical devices or another regulated healthcare product area. 
• Strong organisational skills, attention to detail, and the ability to manage information accurately in a structured environment. 
• Demonstrated ability to work collaboratively and learn quickly.