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Location: Hybrid - 1 day per week on-site in Aachen, Germany
Salary: Competitive, based on experience + Equity
Are you driven by quality and regulatory excellence in medical technology? This innovative start-up is developing a groundbreaking medical device that could expand access to life-saving surgery for millions.
Your Role
1. Develop, implement, and oversee the Quality Management System (QMS).
2. Ensure compliance with ISO 13485, MDR, and 21 CFR 820.
3. Act as Quality Management Representative (QMR) and primary contact for regulatory bodies.
4. Lead internal and external audits, managing regulatory submissions and approvals.
5. Drive continuous improvement initiatives to enhance product and process quality.
Your Profile
1. Extensive experience in quality management within the medical device industry.
2. Strong knowledge of ISO 13485, ISO 14971, MDR, and FDA regulations.
3. Proven track record in leading audits and regulatory compliance processes.
4. Business fluency in English (German is a plus but not required).
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