Lead Cra Medical Device jobs

Description Overview

We are excited to recruit an Associate Professional, Regulatory Affairs within our Medical Device Lifecycle Management team. In this role,you will play an important role in supporting Perrigo's medical device portfolio throughout the product lifecycle. You will contribute to regulatory activities that help maintain ongoing conformity, technical documentation compliance, product availability and market access across multiple regions and markets.

You will support lifecycle management activities including technical documentation updates, change assessments, regulatory notifications, registrations/listings and maintenance of regulatory records in accordance with applicable medical device requirements, approved procedures and business priorities. Working alongside experienced regulatory professionals, you will help ensure documentation remains current, traceable and inspection-ready, and that regulatory deliverables are completed to agreed timelines.

You will manage a range of defined regulatory activities and support change control, product maintenance, labelling updates, technical file remediation and ongoing compliance obligations. You will help identify potential regulatory issues, support risk mitigation activities and contribute to the successful delivery of medical device lifecycle objectives.

Working closely with cross-functional stakeholders including Quality, Safety, Supply Chain, Manufacturing, R&D, Packaging/Artwork, you will provide regulatory support for product and process changes and assist in translating medical device regulatory requirements into practical actions that support compliance and business needs.

You will contribute to the continuous improvement of Medical Device Regulatory Affairs processes, systems and ways of working, helping to improve efficiency, consistency, data quality and inspection readiness across lifecycle activities. Through your role, you will build regulatory expertise in medical devices while supporting Perrigo's commitment to maintaining high standards of compliance, consumer safety and product quality.

This role offers an excellent opportunity to develop a strong foundation in Medical Device Regulatory Affairs, gain experience across the product lifecycle and build both technical and professional capabilities within a dynamic global environment.

Scope of the Role

• Supports ongoing conformity and compliance of medical device products through defined lifecycle regulatory activities across assigned products and markets.
• Delivers routine to moderately complex lifecycle changes, technical documentation updates, regulatory notifications and registration/listing maintenance activities with increasing independence, ensuring compliant and timely execution.
• Builds practical expertise across medical device classifications, markets, regulatory pathways and ways of working while remaining agile to shifting business priorities.
• Focused on executional aspects of medical device lifecycle regulatory work and owns defined deliverables under guidance.
• Assesses and supports routine to moderately complex product, process, labelling and supplier-related changes; prepares and maintains technical documentation, regulatory records, registrations/listings, notifications and conformity-related documentation.
• Works with guidance and review, contributes within project teams, and has impact on defined products, markets, or deliverables.

Lifecycle Compliance & Document Management

• Support the accuracy and compliance of medical device registrations, listings and regulatory records for assigned products and markets.
• Prepare and update technical documentation, technical files and supporting regulatory records with senior review and according to Good Documentation Practice.
• Support labelling, Instructions for Use, packaging and artwork reviews to ensure alignment with approved claims, device requirements and market-specific obligations.
• Support regulatory notifications, registrations/listings and maintenance trackers to ensure lifecycle status and compliance obligations remain visible and current.

Lifecycle Changes and Regulatory Deliverables

• Assess and support routine to moderately complex medical device lifecycle changes under guidance, gathering data and updating technical documentation and regulatory records.
• Draft components for regulatory notifications, registration/listing updates, technical documentation updates and authority or notified body responses; support timeline tracking and follow-up.
• Recommend options for routine change impact assessment, regulatory pathway or documentation approach within delegated scope and escalate uncertainty or higher-risk topics.
• Support implementation tracking following regulatory clearance, notification, listing update or approved documentation change to help avoid compliance gaps and supply disruption.

Risk, Intelligence & Cross-Functional Delivery

• Draft responses to health authority, competent authority or notified body queries and support document reviews under guidance.
• Support regulatory intelligence impact assessments for medical device requirements and inform stakeholders as directed.
• Support audits, inspections, CAPA documentation and follow-up under supervision.
• Partner with Quality, Safety, R&D, Supply Chain, Manufacturing, Packaging/Artwork, Regulatory Operations and local or cluster Regulatory Affairs teams to implement approved changes and maintain ongoing conformity and market compliance.

Experience Required

• Typically 2–4 years in Medical Device Regulatory Affairs, Quality, technical documentation or a related regulatory field; scientific, engineering or technical degree preferred.
• Ability to participate effectively in cross-functional project teams and manage defined deliverables with accuracy and discipline.
• Practical capability in technical documentation preparation, regulatory record maintenance, timeline tracking and structured issue escalation.