Risk Manager & Design Control Engineer - Bonesupport AB

Join BONESUPPORT as Risk Manager & Design Control Engineer and apply your expertise in risk management and design control to ensure patient safety and high-quality products.

Requirements

• Technical academic background at Bachelor level or higher
• At least four years' relevant experience from the medical device industry
• In-depth knowledge of ISO 14971 and medical device regulations (e.g., EU MDR, FDA Quality System Regulation and ISO 13485)
• Hands-on experience with Design Controls as per FDA and ISO 13485
• Strong technical writing and documentation skills
• Ability to interpret and implement regulatory changes into existing systems
• Collaborative mindset with excellent communication and project management skills
• Fluency in English

Benefits

• Competitive salary
• Opportunity to work with a leading Scandinavian biotechnology company
• Collaborative and dynamic work environment