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Senior Consultant – Quality Assurance & Regulatory Affairs (QA/RA) – Software & AI
As a Senior Consultant QA/RA specializing in Software and AI, you will play a key role in supporting our clients in navigating regulatory requirements for medical device software (MDSW) – from early concept and development through market access and post-market surveillance.
You will advise and work hands-on with defining the regulatory strategy, building and implementing an efficient Quality Management System (QMS) and Technical documentation for the device throughout its lifecycle, aligned with applicable regulatory frameworks needed to bring safe and sometimes life-saving devices to market.
You will collaborate closely with colleagues from the QA/RA and the Clinical Evaluation teams and support our clients throughout the device lifecycle; in connection with software development, risk management, submissions to Competent Authorities/Regulatory Agencies, audits and post‑market surveillance. Your ability to interpret regulations and standards, assess compliance gaps, and translate them into practical and actionable guidance will be central to success in this role.
Your work strengthens our clients’ capabilities in an evolving regulatory landscape and contributes to innovative, safe and user friendly digital medical technologies.
Your responsibilities
- Guide clients in interpreting and applying applicable standards and guidance, including:
- Software-related standards such as IEC 62304, IEC 82304‑1 and IEC 81001-5-1 as well as emerging AI‑specific frameworks
- General medical device-related standards such as ISO 13485, ISO 14971, EN 62366-1 and IEC/TR 20416
- Support clients in building, implementing and updating QMS with processes aligned with ISO 13485 and relevant regulatory frameworks, e.g. MDR (EU market) or QMSR (US market)
- Support clients in building and updating Technical documentation aligned with relevant standards and regulatory frameworks, e.g. MDR (EU market) or FDA 510(k)-requirements (US market)
- Conduct GAP assessments to MDR, ISO 13485, device related standards or requirements from other global markets
- Support clients in defining the regulatory strategy, including qualification and classification, intended purpose, and conformity assessment pathways under EU MDR or regulatory frameworks of other markets
- Support clients in certification processes for their device, including:
- Interactions with Notified Bodies and Competent Authorities/Regulatory Agencies
- Ensuring audit readiness
- Managing nonconformities
- Mentor colleagues, share expertise, and support capability‑building within software and AI compliance. Contributing with content knowledge for our Education programs.
Who you are
You have practical experience working with medical device software (MDSW). You understand how regulations, standards, and guidance apply to software development activities and documentations, and can confidently support clients in meeting these requirements.
You navigate complex regulatory environments with ease. You are analytical, structured, independent, a strong communicator and comfortable working across small/mid/large client organizations. You are service-minded, solutions-oriented and comfortable providing customized assistance for our clients, with their best interest in mind.
- Experience with QMS and technical documentation aligned with EU and/or US market requirements and software related standards is highly advantageous
- Experience with AI/ML regulatory frameworks, cybersecurity or data governance, or National medical information systems (NMI, Swedish regulation HSLF-FS 2022:42) is a strong merit
You are fluent in English, both spoken and written. You express yourself clearly and professionally in writing.
Swedish is an advantage but not a requirement for this role.
BSc, MSc in a relevant field (e.g. medical or biotechnology engineering, computer science), experience of consultancy work or extensive work experience in Quality Assurance or Regulatory Affairs is beneficial.
Why GBA Key2Compliance?
Working at GBA Key2Compliance means making a meaningful impact every day. Your expertise directly strengthens our clients’ clinical and regulatory capabilities and ultimately enhances patient safety. You will be part of a highly skilled team that values collaboration, knowledge‑sharing, and continuous learning.
We offer a supportive, low‑prestige environment with a mix of structure and entrepreneurial spirit — a place where you can grow professionally while contributing to work that truly makes a difference.
Practical information
Workplace: Stockholm, Gothenburg or Lund
Travel: May occur occasionally depending on client needs
Hybrid work: Possible depending on operational requirements
If you have questions about the position, please send them to hr.k2c@key2compliance.com