Regulatory Specialist

A leading medical device company in the field of robotic surgery is looking for a motivated and detail-oriented Regulatory Specialist to join our team. This is an exciting opportunity to be part of a dynamic startup environment as we transition from development to commercial operations.

Key Responsibilities

Prepare and maintain regulatory documentation, including Technical Documentation and Design Dossiers for products marketed in the EU.

Prepare regulatory submissions, particularly in compliance with EU Medical Device Regulation (MDR).

Assess the impact of product or process changes on regulatory strategy and documentation.

Ensure compliance with EU MDR 2017/745 and support inspections and audits.

Review clinical evaluation reports, risk management reports, and FMEAs.

Monitor regulatory changes and update internal teams accordingly.

Provide training and support on regulatory requirements and best practices.

Manage product registrations and regulatory communications.

What We're Looking For

Bachelor’s degree in Life Sciences, Engineering, or a related field; an advanced degree is a plus.

3-5 years of experience in regulatory affairs within the medical device industry.

Proven experience with CE marking.

Strong knowledge of EU MDR and relevant regulatory requirements.

Excellent attention to detail and ability to work independently.

Strong written English and verbal communication skills.