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QA/RA Medical Device Software Specialist
2 months ago
Job Description:
Role Summary:
We are seeking a highly skilled QA/RA specialist to join our team at PlantVision AB. As a QA/RA specialist, you will play a key role in ensuring the quality and regulatory compliance of our medical device software.
Key Responsibilities:
- Lead quality assurance and regulatory activities for our medical device software products.
- Develop, optimize, and digitalize quality processes and regulatory activities for 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 throughout the product development lifecycle.
- Develop and maintain relationships with customers to understand their specific needs and requirements.
- Contribute to the development of our quality management system and ensure its effectiveness.
Requirements:
- Minimum 5 years of experience in software development and regulatory activities for medical devices.
- Strong knowledge of regulatory requirements and standards for medical devices, including MDR/IVDR, ISO 13485, IEC 62304, and IEC 82306.
- Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.
- Strong analytical and problem-solving skills, with the ability to identify and resolve complex quality and regulatory issues.
- Ability to work independently and as part of a team, with a strong focus on quality and regulatory compliance.
What We Offer:
- A dynamic and innovative work environment with a strong focus on quality and regulatory compliance.
- Opportunities for professional growth and development, with a focus on quality and regulatory expertise.
- A competitive salary and benefits package.
- A collaborative and supportive team environment.
How to Apply:
If you are a motivated and experienced QA/RA specialist looking for a new challenge, please submit your application, including your resume and a cover letter, to [insert contact information].
