Support compliance across EU MDR, UK MDR, FDA, TGA, and Health Canada frameworks.
Prepare and maintain Declarations of Conformity and product regulatory documentation.
Manage FDA establishment registration, device listings, and renewal obligations.
Coordinate market registrations and authorisations globally, tracking deadlines and submission status.
Support IEC electrical safety standard compliance (IEC 60335-2-27, IEC 62368-1, IEC 62471, IEC 60825-1) across the product portfolio.
Monitor regulatory changes and ensure timely updates to internal documentation and processes.
Maintain compliance registers covering REACH/RoHS, environmental requirements, and market authorisations.
Liaise with certification bodies, testing labs, and EU/UK Authorised Representatives.
Respond to regulatory queries, import alerts, and market surveillance activities.
Partner with NPD, Supply Chain, Marketing, and Operations to embed regulatory requirements throughout product development.
Maintain regulatory trackers, gate review documents, and compliance calendars with clear stakeholder updates.
Coordinate with suppliers and testing labs to obtain and file certifications, test reports, and regulatory documentation.

Degree in a scientific, engineering, business, or regulatory discipline — or equivalent experience.
Experience in a regulatory, quality, or compliance role — sector and seniority are flexible.
Familiarity with at least one of: EU MDR, UK MDR, FDA device regulations, TGA, Health Canada, ISO 13485, or cosmetics compliance (EU 1223/2009).
Strong attention to detail and a structured approach to documentation and record-keeping.
Clear written communicator; comfortable liaising with internal teams and external partners.
Organised and able to manage multiple workstreams with competing deadlines.
Broader exposure across multiple regulatory frameworks (e.g. FDA and TGA, or devices and cosmetics).
Experience with NMPA, MFDS, or other APAC market requirements.
Familiarity with REACH, RoHS, WEEE and environmental compliance obligations.
Experience in a DTC, e-commerce, or consumer brand environment.
Experience using regulatory management, PLM, or project tracking tools.

Regulatory Compliance Specialist

About this role