Regulatory Strategy Lead - Medical Devices & Software

Raysearch Laboratories AB (Publ); Solna kommun; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

RaySearch Laboratories AB is seeking an experienced Regulatory Lead to own the regulatory strategy and lifecycle oversight for a RaySearch product. You will be the main regulatory contact, partnering with Development, Corporate Strategy and Sales to shape strategy and drive market access.

This high-visibility role combines regulatory expertise with strategic thinking, project coordination, and collaboration across the organization in a fast-paced environment.

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related field.
• Several years of Regulatory Affairs experience within the medical device industry.
• Strong experience preparing and reviewing Technical Documentation under EU MDR.
• Experience working with medical device product development and design control processes.
• Experience with medical device software.
• Strong knowledge of IEC 62304, IEC 60601 and ISO 14971.
• Strong project management and stakeholder management skills.
• Proficiency in English.

Responsibilities

• Own and drive the global regulatory strategy for your product throughout its lifecycle.
• Lead the preparation, review, and maintenance of Technical Documentation and regulatory submissions, including EU MDR.
• Act as the regulatory expert within development projects and ensure regulatory requirements are integrated throughout the design and development process.
• Coordinate and oversee multiple projects, priorities, and submission timelines while maintaining a long‑term view of the product roadmap.
• Partner closely with Development, Corporate Strategy, Sales and other key stakeholders to support product development and market access.
• Support inspections, audits, post‑market activities, and continuous improvements.

Skills

Regulatory Affairs

Technical Documentation

Medical Device Software

IEC 62304

IEC 60601

ISO 14971

Project Management

Stakeholder Management

English Proficiency

Education

Bachelor's or Master's degree in Engineering/Life Sciences/Regulatory Affairs

Job description

RaySearch Laboratories AB is seeking an experienced Regulatory Lead to own the regulatory strategy and lifecycle oversight for a RaySearch product. You will be the main regulatory contact, partnering with Development, Corporate Strategy and Sales to shape strategy and drive market access.

This high-visibility role combines regulatory expertise with strategic thinking, project coordination, and collaboration across the organization in a fast-paced environment.