Regulatory Compliance Officer

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!

At System C, we prioritise transparency in our job requirements and selection criteria, ensuring they are based solely on the essentials needed for effective job performance. We consciously avoid assumptions that could skew our perception of a candidate’s suitability for hire.

Our recruitment practices are designed to ensure that no applicant is unfairly disadvantaged by procedures or requirements that disproportionately affect protected groups without being essential for the job.

For every position, we develop a detailed job description and person specification. This approach maintains our focus on the true demands of the role and the skills, experience, and qualifications necessary. During interviews, we involve multiple interviewers where possible to further mitigate unintentional bias, thereby promoting a fair and equitable hiring process.