Regulatory Affairs Manager (m/f/d)

Job title: Regulatory Affairs Manager (m/f/d)

Industry: Medical Devices

Skills: Regulatory, ISO 13485

Start date: ASAP

Location: Geneva, Switzerland

The Aristo Group is a Recruitment focused solution provider in the life sciences industry. Our goal is to find the “perfect match” for our customers and candidates.

We are now looking for an experienced Regulatory Affairs Manager to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.

Main duties

• This role primarily supports the advancement of our Diabetes Care division, particularly focusing on active and connected devices.
• Responsible for devising and executing regulatory strategies throughout the development process.
• Assist in preparing and coordinating product submission documentation, with a primary emphasis on EU and US markets.
• Collaborate closely with stakeholders across various organizational levels.
• Manage communication and correspondence with regulatory authorities.
• Participate in Quality Management System (QMS) audits, ensuring compliance with ISO 13485 and 21 CFR 820 standards.
• Undertake general Quality Management (QM) tasks such as creating Q-documents and conducting trainings.

Qualifications

•  Bachelors Degree in Engineering or relevant field.
• Minimum 5 years of professional experience in Regulatory Affairs, Medical devices sector.
• Proficient in regulations, guidance documents in EU/US Markets.
• Fluent in English, French and German advantageous.

For further information about this position, please apply with your CV or contact me directly via linkedIn.

*Please note, only those with the right to work in Switzerland can apply*