Regulatory Compliance Officer
| Posting date: | 19 March 2025 |
|---|---|
| Hours: | Full time |
| Closing date: | 18 April 2025 |
| Location: | Liverpool, L3 1DG |
| Company: | System C |
| Job type: | Permanent |
| Job reference: | REQ750 |
Summary
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!