Regulatory Compliance Officer

System C; City of Edinburgh; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A healthcare technology company is seeking a Regulatory Compliance Officer in Edinburgh. This role involves developing regulatory strategies for healthcare software products, ensuring compliance with UK and international regulations. The ideal candidate will have a Bachelor’s degree in a related field and experience in regulatory affairs within IT, as well as strong analytical and communication skills. Join us to help shape the future of healthcare technology!

Benefits

Flexible working

Career growth opportunities

Make an impact in healthcare

Qualifications

• Demonstrable experience in regulatory affairs within an IT software organization.
• Knowledge of UK MDR and EU MDR frameworks.
• Experience preparing regulatory documentation.

Responsibilities

• Develop and implement regulatory strategies for healthcare technology.
• Act as the main point of contact with regulatory bodies.
• Support post-market surveillance and safety actions.

Skills

Analytical skills

Communication

Project Management

Education

Bachelor’s degree in Regulatory Affairs or related field

Job description

System C Edinburgh, Scotland, United Kingdom

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System C Edinburgh, Scotland, United Kingdom

Join to apply for the Regulatory Compliance Officer role at System C

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

  Hospitals and Health Care

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