Quality & Regulatory Specialist, Software Medical Devices

RaySearch Laboratories; Stockholms kommun; On-site; SEK 650,000 - 780,000; Full time

Job summary

RaySearch Laboratories seeks a Quality Specialist to join our Quality & Regulatory Affairs team in Stockholm. You will help maintain and improve our QMS, ensuring regulatory compliance for our software medical devices and related products.

You will collaborate across teams to support audits, drive continuous improvement, and balance quality with business needs using a pragmatic, risk-based approach. English proficiency and strong communication are essential.

Qualifications

• 3+ years of experience working with Quality Management Systems in the medical device industry.
• Bachelor's or Master's degree in Engineering, Life Sciences, Medical Technology, Quality Management, or related field.
• Good understanding of quality processes such as: CAPA, Non-conformities, Change control, Internal audits, Management reviews.
• Knowledge of ISO 13485 and medical device regulatory requirements.
• Experience from software medical devices is highly desirable.
• Strong communication and collaboration skills.
• Ability to work independently and drive activities forward.
• Able to balance compliance requirements with business needs using a risk-based mindset.
• Very good command of English, both spoken and written.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS), related quality processes, and electronic QMS platforms.
• Manage and support CAPA, non-conformity, and change control activities.
• Plan, conduct, and follow up on internal audits.
• Support external audits, inspections, and supplier audits as needed.
• Support the management review process and quality performance monitoring.
• Review quality records and documentation to ensure compliance with company procedures and regulatory requirements.
• Support process improvements and help drive a culture of continuous improvement throughout the organization.
• Provide guidance and support to colleagues on quality processes and QMS requirements.

Skills

Quality Management Systems

ISO 13485

Medical device quality

English proficiency

Communication & collaboration

Risk-based mindset

Independent work

Regulatory understanding

Education

Bachelor's or Master's degree in Engineering, Life Sciences, Medical Technology, Quality Management, or related field

Job description

RaySearch Laboratories seeks a Quality Specialist to join our Quality & Regulatory Affairs team in Stockholm. You will help maintain and improve our QMS, ensuring regulatory compliance for our software medical devices and related products.

You will collaborate across teams to support audits, drive continuous improvement, and balance quality with business needs using a pragmatic, risk-based approach. English proficiency and strong communication are essential.