Regulatory Compliance Officer - #1780331

Description

Are you passionate about ensuring healthcare technology meets the highest regulatory standards? Do you have a strong background in compliance and a keen eye for detail? If so, we have an exciting opportunity for you to join our Audit, Compliance & Certification team as a Regulatory Compliance Officer.

At System C, we are dedicated to transforming healthcare through cutting-edge software solutions. Our products are designed to improve patient outcomes, enhance clinical workflows, and drive efficiencies in healthcare systems. To maintain our high standards, we are looking for a Regulatory Compliance Officer to ensure our SaMD (Software as a Medical Device) products adhere to UK and international regulations.

What You’ll Do

As a key member of our compliance team, you will:

• Develop and implement regulatory strategies for new and existing products, ensuring compliance with evolving regulations.
• Ensure adherence to UK Medical Devices Regulations and relevant international standards, including ISO 13485, ISO 14971, and IEC 62304.
• Prepare and maintain regulatory documentation to support product registrations and approvals.
• Act as the main point of contact with regulatory bodies, such as the Medicines and Healthcare products Regulatory Agency (MHRA).
• Support post-market surveillance activities, including adverse event reporting and safety actions.
• Provide regulatory training and guidance to internal teams, fostering a culture of compliance.
• Collaborate with R&D and product teams, offering regulatory insights throughout the product lifecycle.
• Identify and mitigate regulatory risks, ensuring that compliance challenges are addressed proactively.
  
  

What We’re Looking For

• A Bachelor’s degree or relevant professional experience within Regulatory Affairs, Health/Life Sciences, or a related field.
• Demonstrable experience in regulatory affairs, particularly within an IT software organisation that develops and deploys SaMD.
• Strong knowledge of UK MDR, EU MDR, and relevant international regulatory frameworks.
• Excellent analytical, communication, and project management skills.
• Ability to work both independently and collaboratively across teams.
  
  

Why Join Us?

• Make an impact – Your work will contribute to safer and more effective healthcare solutions.
• Innovate with us – Work at the cutting edge of healthcare technology.
• Career growth – Be part of a team that values learning and professional development.
• Flexible working – Enjoy a hybrid work environment that supports work-life balance.
  
  

If you’re looking for a meaningful career in regulatory compliance and want to be part of a company making a difference in healthcare, we’d love to hear from you!

Apply now and be part of the future of healthcare technology!