Advanced Regulatory Affairs Specialist

As part of the EMEA Regulatory Affairs team, you will participate in all regulatory activities related to the import and distribution of ResMed products in the EMEA region—from product registrations to follow‑up of product changes and post‑market activities. You will work on European processes with other functions to ensure overall compliance of ResMed activities in EMEA and act as the interface between the legal manufacturer and country partners to ensure coordination and proper coordination. Finally, you will contribute to the implementation of the new European regulation on medical devices and the control/registration of products placed on the European market.

Key Responsibilities

• Collaborate on the evaluation of regulatory requirements, preparation, planning, submission, archiving and maintenance of product registrations in the European region & MENA countries to achieve timely approvals in accordance with commercial distribution and regulatory strategic plans.
• Collaborate and interact with local regulatory partners, legal manufacturers/production sites, and other on‑site functions to obtain required information and documents for registrations.
• Verify the relevance of the information to prepare the registration file.
• Provide documentary support for the preparation of registrations: FSC, statement letters, formatting of documents.
• Review labeling to ensure compliance with relevant regional and national requirements.
• Analyze and assess new local regulations related to product registrations, especially in the MEA region, and participate in regulatory watch.
• Support regulatory requests received from the field (e.g., from customers, customs).
• Participate and contribute to the implementation of global or regional regulatory tools.
• Contribute to projects as a cross‑functional member; represent the Regulatory function and provide regulatory assessments and inputs.
• Participate in economic operators’ verification activities.

Qualifications

• Bachelor’s Degree in Science or Engineering with first experience in Regulatory Affairs positions in a similarly regulated medical industry.
• Knowledge of Medical Device Regulatory Framework.
• Fluent in English (read, spoken, written).

Preferred:

• At least 5 years of experience in Regulatory Affairs positions in a similarly regulated medical industry.
• Experience in medical device registration file preparation.
• Knowledge of Regulatory Information Management Systems.
• Very good organizational, administrative and writing skills.
• Good interpersonal, intercultural, and communication skills.
• Autonomy and capacity to work remotely.

Additional Information

• All employees benefit from a bonus plan, the percentage of which depends on your position within the organisation.
• Working from home flexibility.
• Access to a referral bonus and ResMed’s preferred shareholding programme.
• Internal career opportunities in a fast‑paced and massively growing company.

Joining us is more than saying “yes” to making the world a healthier place. It’s discovering a career that’s challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. If this sounds like the workplace for you, apply now!