TestCard Hiring for Software Compliance Writer Job at Edinburgh, Scotland Full Time

Job Brief

As a Software Compliance Writer, you will be joining a fast-paced environment and accomplished software development and compliance team. You will engage regularly with technical leads, product designers, regulatory and quality assurance team members – supporting the critical documentation of our medical device and leading the certification of our software components.

Methodical and organised working practices are essential in this role. We expect the candidate to become familiar with current standards and regulations and to work in conjunction with the Quality/Regulatory and technical team to assure compliance and the high quality of our operations and services.

Job Type: Full-time, Permanent

Location: UK (Remote) or Edinburgh (preferred)

Salary: £40 – 50K depending on experience

Activities and responsibilities:

As a Software Compliance Writer, you will be responsible for:

General

• Leading day-to-day software related regulatory compliance activities for TestCard’s IVD medical devices.

• Understand and improve internal software development processes according to IEC 62304:2006 +A1:2015 and EN ISO 13485:2016.

• Research for, and alignment of, software related documents with medical device regulatory requirements for submissions under:

• US FDA 510(k)

• EU IVDR (CE marking)

• UKCA

• Work with interested parties throughout the business to support software regulatory compliance activities primarily relating to:

• UKCA Marking for In Vitro Diagnostic Devices

• In Vitro Diagnostic Regulation 2017/746

• FDA Quality System Regulation 21 CFR Part 820

• Care Quality Commission Registration Regulations

• EN ISO 13485:2016

• ISO 14971:2019

• IEC 62304:2006 +A1:2015

• ISO 27001:2013

• UK Data Protection Act 2018 & EU GDPR

• NHS Data Security & Protection Toolkit

• Health Insurance Portability and Accountability Act 1996 (HIPAA)

• Maintain an up to date personal training record.

• Work within the requirements of the quality management system

Pre-market

• Document and support regulatory requirements for UKCA / EU IVDR certification and for US 510(k) clearance from a software perspective (e.g. Technical File, Performance Evaluation Report, Risk/Hazard Management etc).

• Preparing software regulatory documentation for submission to certification bodies, UK Approved Bodies, Notified Bodies, and Federal Agencies.

• Lead the documentation and management of the software design history files and associated technical files to ensure their regulatory compliance in the pre-market phase.

• Work closely with the Quality, Regulatory and Technical teams to respond to software-related questions from Certification Bodies, UK Approved Bodies, Notified Bodies, Competent Authorities & Federal Agencies.

• Post-market*
• Lead the management of the software design history files and associated technical files to ensure their continued regulatory compliance in the post-market phase.

• Work closely with the Quality, Regulatory and Technical teams to respond to software-related questions from Certification Bodies, UK Approved Bodies, Notified Bodies, Competent Authorities & Federal Agencies in response to vigilance activities.

Essential experience

• Experience in the Medical Devices industry (preferably within In Vitro Diagnostics) ideally within a start-up environment

• Experience working within Quality Assurance and/or Regulatory Affairs (preferably in medical device submission for UKCA, CE and/or US FDA 510k)

• Experience (3+ years) of working with Software Medical Devices supporting software engineers to achieve compliance with the requirements of the IEC 62304 standard

• Knowledge of the GDPR, HIPAA and other global data protection regulations

Further Desirable experience

• Previous experience working with Mobile Apps as Medical Devices

• Previous experience working as a Software Engineer

• Degree in Software Engineering or similar STEM subject

• Information Security and ISO 27001 ISMS Administration experience

• Experience in establishing/improving Software Development Lifecycle Processes

PERSONAL QUALITIES

• Hardworking result-oriented person

• Diligent and conscientious

• Keen to work in a small target-focussed team

• Ability to perform effectively in complex environments

• Ability to think of the bigger picture whilst able to focus on details where required

Job Types: Full-time, Permanent

Salary: £40,000.00-£50,000.00 per year

Benefits:

• Work from home

Schedule:

• Monday to Friday

Application question(s):

• Do you have experience working within the Medical Device industry?
• Do you have experience working within Regulatory Affairs and/or Quality Assurance?

Experience:

• Software as a medical device: 3 years (preferred)