VP of QA/RA - MedTech - Sweden

Title: VP of Quality & Regulatory Affairs

Currently partnered with a leading medical device company specializing in the development and manufacturing of high-risk medical devices. With a workforce of over 200 dedicated employees, they are committed to delivering innovative solutions that improve patient outcomes and advance healthcare standards worldwide. Their mission is to ensure the highest quality and regulatory compliance in every aspect of our operations, from product development to post-market surveillance..

They are seeking a dynamic VP of Quality & Regulatory Affairs to lead their quality assurance and regulatory compliance efforts.

Key Responsibilities:

• Develop & implement a robust quality management system.
• Ensure compliance with FDA regulations, ISO standards, and global requirements.
• Lead regulatory strategy and submissions for new product approvals.
• Foster a culture of continuous improvement and quality excellence.
• Collaborate cross-functionally to align quality objectives with business goals. 

Qualifications:

• Bachelor's degree: advanced degree preferred. 
• 10+ years in quality assurance and regulatory affairs in the medical device industry.
• Strong leadership, communication, and strategic thinking skills.
• Proven track record in regulatory submissions and approvals.
• Certification in quality management and regulatory affairs is desirable.