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QA/RA Medical Device Software Specialist

2 months ago

Stockholm, Stockholm, Sweden Plantvision AB Full time
About the Role

We are seeking a highly skilled and experienced QA/RA specialist to join our team at Plantvision AB. As a QA/RA specialist, you will play a crucial role in ensuring the quality and regulatory compliance of our medical device software.

Key Responsibilities
  • Lead quality assurance activities for our medical device software products
  • Develop, optimize, and digitalize quality processes and regulatory work related to medical device software development
  • Promote and implement regulatory requirements and standards, such as MDR/IVDR, ISO 13485, IEC 62304, and IEC 82306
  • Collaborate with cross-functional teams to ensure quality and regulatory compliance
  • Develop and maintain relationships with customers to understand their specific needs and requirements
Requirements
  • Minimum 5 years of experience in software development for medical devices
  • Proven track record of ensuring quality and regulatory compliance in a medical device software development environment
  • Strong understanding of regulatory requirements and standards, such as MDR/IVDR, ISO 13485, IEC 62304, and IEC 82306
  • Excellent communication and collaboration skills
  • Ability to work independently and as part of a team
What We Offer
  • A dynamic and innovative work environment
  • Opportunities for professional growth and development
  • A competitive salary and benefits package
  • A chance to work with a talented and passionate team