Regulatory Affairs Specialist - Consultant (Medical Devices) na ClinChoice

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Regulatory Affairs Specialist - Consultant (Medical devices) for 12 months Contract with possibility of extension to join one of our medical devices clients.

We are looking for a dedicated and detail-oriented Regulatory Affairs Specialist to join our Regulatory team in Zuchwil, Switzerland. In this role, you will be responsible for supporting global market registrations, maintaining product licenses, and ensuring regulatory compliance for our innovative medical devices. You will collaborate closely with cross-functional teams to enable timely market access and continued compliance with international regulatory requirements.

Key Responsibilities

• Support market registrations and license renewals for medical devices in various global regions.
• Prepare, compile, and maintain regulatory documentation to support international registrations and tender requests.
• Prepare timely and accurate responses to questions and requests from health authorities related to product registrations.
• Manage proprietary and confidential documentation to ensure the protection of intellectual property.
• Ensure compliance with applicable medical device regulations, standards, and guidance (e.g., EU MDR, ISO 13485, FDA 21 CFR).
• Identify and implement solutions to a variety of regulatory challenges of moderate scope and complexity.
• Maintain and archive all regulatory documentation in accordance with internal quality system procedures and regulatory requirements.

Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related discipline.
• 2+ years of experience in Regulatory Affairs within the medical device industry.
• Solid understanding of international medical device regulations (EU MDR, ISO 13485, FDA requirements, etc.).
• Experience preparing and submitting technical documentation and registration dossiers.
• Strong organizational skills and attention to detail with the ability to manage multiple priorities.
• Excellent written and verbal communication skills in English (German language skills are an advantage).
• Ability to work independently while collaborating effectively in a cross-functional, global environment.

#LI-PR1 #LI-Hybrid