14 days ago
Full-time
Mid Level
#ai#brustkrebs#diagnose
Team Lead Quality & Regulatory Affairs
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Intro
As the Team Lead Quality & Regulatory Affairs, you will be responsible for developing and executing regulatory strategies on a global scale while overseeing and maintaining the quality management system (QMS) in compliance with ISO 13485.
Tasks
- Develop and implement comprehensive regulatory strategies aligned with business objectives and market access plans.
- Oversee the preparation, submission, and maintenance of regulatory filings globally.
- Lead and maintain the QMS in accordance with ISO 13485 standards.
- Ensure safety and compliance of our QMS processes as the Person responsible for Regulatory Compliance.
- Provide training and support to staff on QMS processes, regulatory requirements, and best practices.
- Manage internal and external audits to ensure compliance with regulatory requirements.
- Drive continuous improvement initiatives within the organization.
- Monitor and develop the organization’s data processing strategies to ensure compliance with GDPR and other applicable data protection laws.
- Provide training and support to staff on data protection obligations and best practices.
- Act as the in-house quality and regulatory expert, advising and supporting internal and external stakeholders.
- Collaborate with cross-functional teams to ensure regulatory and quality compliance throughout the product lifecycle.
Requirements
- Bachelor’s degree or higher in a relevant field (e.g., Engineering, Life Sciences, Quality Management).
- Minimum of 5 years of experience in the management of QMS within the medical device industry, with a strong understanding of ISO 13485.
- Proven leadership experience with strong decision-making capabilities.
- Extensive knowledge of global regulatory requirements and submission processes.
- Excellent communication, negotiation, and interpersonal skills.
- Strategic thinking and problem-solving abilities.
- High attention to detail and accuracy.
- Flexibility and adaptability to work in a fast-paced, dynamic environment with changing market conditions.
- Fluent English, German highly desired.
Benefits
- Work flexibly - In-office, from home, or somewhere in between.
- Team Culture - Regular team nights and events to foster company culture and cohesion.
- Connect at our AI Campus - Meet exceptional individuals and participate in inspiring events.
- Competitive salary - Regular benchmarking within the tech and healthcare industry.
- Develop your career - Engage in impactful projects and meaningful career development sessions.
14 days ago
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