Specialist, Regulatory Affairs (Medical Devices)

Location: Onsite in Neuchatel, Switzerland

English is essential.

Company

Develops and commercializes innovative medical technologies for international markets.

What you will do

• Prepare and submit national regulatory applications across the EU region.
• Manage EU registrations, notifications, renewals, changes, and EUDAMED activities.
• Maintain regulatory files, certificates, licenses, databases, and document-control records.
• Assess the regulatory impact of medical device changes against national requirements.
• Coordinate distributor authorization documents and support customer service, marketing, and sales with market approvals.
• Assist with regulatory meetings and provide day-to-day support to the Regulatory Affairs team.

Requirements

• Experience with EU regulatory requirements for CE-marked medical devices.
• Knowledge of ISO 13485 and EN ISO 14971 requirements.
• Strong documentation, record-tracking, prioritization, organizational, and communication skills.
• Proficiency in Microsoft Office, including Outlook, Excel, Word, and PowerPoint.
• Ability to work collaboratively with local and non-local leadership, independently, and with minimal supervision.
• Ability to work from the Neuchatel office in Switzerland.

Nice to have

• 2–5 years of EU regulatory experience in a medical device company.
• Experience with SharePoint and Oracle Agile PLM.
• Experience in international corporations and global regulatory frameworks such as FDA and UKCA.
• Bachelor’s degree in life sciences, engineering, law, or medical/healthcare, or equivalent experience.

Culture & Benefits

• Work in a collaborative international organization.
• Collaborate with cross-functional stakeholders and regulatory teams across Europe and global markets.
• Contribute to the registration and commercialization of medical technologies across the EU and UK.