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
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!
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Legal
* Industries
IT Services and IT Consulting
Referrals increase your chances of interviewing at System C by 2x
Get notified about new Compliance Officer jobs in Oxford, England, United Kingdom.
Analyst - Financial Crime Compliance - London, High Wycombe or Bristol
High Wycombe, England, United Kingdom 1 month ago
Stone, England, United Kingdom 5 days ago
Reading, England, United Kingdom 5 days ago
Head of Technology Governance, Risk, and Compliance (GRC)
Reading, England, United Kingdom 21 hours ago
Global Head of Information Security and Data Protection
Global Head of Information Security and Data Protection
Aylesbury, England, United Kingdom 6 days ago
Compliance Officer (Marketing and Distribution Compliance)
Oxfordshire, England, United Kingdom 6 days ago
GMP Quality & Compliance Officer Logistics
Abingdon-On-Thames, England, United Kingdom 6 days ago
Oxford, England, United Kingdom 1 month ago
Communications Data Investigator (Secondment/Fixed Term Contract)
Kidlington, England, United Kingdom 1 week ago
Reading, England, United Kingdom 4 days ago
Reading, England, United Kingdom 1 week ago
Reading, England, United Kingdom 3 weeks ago
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr