Head of Regulatory Affairs (m/f/d)

Job title: Head of Regulatory Affairs (m/f/d)

Industry: Medical Devices

Skills: Regulatory, ISO 13485

Start date: ASAP

Location: Zurich, 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 Head of Regulatory Affairs to join a Global MedTech company to work on innovative products benefiting the healthcare of millions.

Main duties

• Develop a comprehensive regulatory strategic roadmap aligned with business objectives, providing regulatory guidance for pre-market and post-market programs.
• Contribute to critical strategic decisions influencing the enhancement of global regulatory compliance processes and protocols.
• Stay abreast of new requirements through regulatory intelligence processes, adjusting strategies as needed.
• Supervise the compilation of regulatory submission files for new products and modifications, ensuring timely submissions and approvals.
• Participate in and review responses to inquiries from Notified Bodies and the FDA to ensure comprehensive and consistent answers.
• Support life-cycle management activities, including assessing regulatory impacts for changes
• Guarantee product compliance
• Lead preparatory activities, including assembling briefing packages for interactions with the FDA.
• Foster effective communication within the global Regulatory Affairs team.

Qualifications

• Bachelors degree in a scientific field
• Min 5 years of professional experience in Regulatory Affairs (RA) and Quality Management (QM)
• Demonstrated enjoyment and proficiency in managing and maintaining quality documents with precision
• Adaptable team player with a structured approach, capable of thriving in dynamic work environments
• Ability to perform well under pressure and adeptly prioritize tasks
• Fluent in English, French or 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*