Senior Quality & Regulatory Specialist

TFS HealthScience

Stockholm, Sweden
On-site
Quality management system (qms) implementation
Technical documentation for samd
Mdr 2017/745 compliance
Support a large public healthcare organization in establishing, adapting, and implementing a quality management system (QMS) and technical documentation in line with NMI (HSLF-FS 2022:42), MDR 2017/745, and relevant standards such as ISO 13485 and IEC 62304

Job Summary

  • Support a large public healthcare organization in establishing, adapting, and implementing a quality management system (QMS) and technical documentation in line with NMI (HSLF-FS 2022:42), MDR 2017/745, and relevant standards such as ISO 13485 and IEC 62304.
  • Collaborate with stakeholders to define roles, responsibilities, and organizational setup for quality and regulatory functions (including PRRC considerations).
  • We provide opportunities for personal and professional growth in a rewarding environment.

Matching Summary

Support a large public healthcare organization in establishing, adapting, and implementing a quality management system (QMS) and technical documentation in line with NMI (HSLF-FS 2022:42), MDR 2017/745, and relevant standards such as ISO 13485 and IEC 62304.

Skills & Requirements

Must-have

  • Quality Management System (QMS) implementation
  • Technical documentation for SaMD
  • MDR 2017/745 compliance
  • ISO 13485 and IEC 62304
  • Risk management and usability support

Nice-to-have

  • Experience in public healthcare
  • Support for notified body certifications
  • eQMS evaluation and implementation
  • NMI and MDR frameworks experience

Key Requirements

  • Minimum 5 years of experience in QA/RA
  • Hands-on QMS implementation and technical documentation
  • Experience with ISO 13485 and IEC 62304
  • Fluency in Swedish and English

Work Rights

Not specified

Tailored Resume

Cover Letter