Job Title

We are seeking Labelling Support Engineer to join our medical device development team on a 1 - Year contract. The successful candidate will be responsible for designing, reviewing, and maintaining product Labelling in compliance with global regulatory requirements. This role ensures that all Labelling (IFUs, packaging, product inserts, electronic Labelling) meets quality standards, supports usability, and aligns with corporate branding.Experience Range: 7-8 YearsKey Responsibilities:Develop and maintain Labelling content for medical devices, including Instructions for Use (IFUs), packaging labels, and electronic Labelling.Ensure compliance with international regulatory standards (FDA, EU MDR, ISO 15223, IEC 60601, etc.).Collaborate with cross-functional teams (Regulatory Affairs, Quality Assurance, R&D, Marketing, Manufacturing).Manage Labelling to change control processes and documentation within PLM/QMS systems.Conduct risk assessments related to Labelling errors and usability.Support audits and inspections by providing Labelling documentation.Coordinate translations and localization for global markets.Ensure Labelling aligns with corporate design guidelines and patient safety requirements.Qualifications:Bachelor’s degree in engineering, Life Sciences, Regulatory Affairs, or related field.7 - 8 years of experience in medical device Labelling or regulatory documentation.Strong knowledge of FDA 21 CFR Part 801, EU MDR Annex I, ISO 13485, and ISO 15223, ISO 20417 standards.Experience with PLM/QMS systems (Windchill).Familiarity with artwork management tools and Labelling software.Excellent attention to detail and strong organizational skills.Ability to work in a cross-functional, global environment.Preferred Skills:Experience with electronic Labelling (eIFU) and digital platforms.Knowledge of human factors engineering and usability studies.Multilingual capability or experience managing translations.Project management experience in regulated industries.