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Quality & Regulatory Manager
1 open positions
About the role:
Minze Health is a Belgian company, driven by a small yet talented team, that develops impactful medical products for patients suffering from incontinence and other urological conditions. It is our daily mission to improve the quality of life of these patients with our screening and remote monitoring solutions for the patient’s condition.
Committed to delivering high-quality products that make a meaningful impact, we are expanding our team and seeking a dynamic Quality & Compliance Manager to join us on our journey.
As a Quality & Compliance Manager, you will play a pivotal role in ensuring our products meet and exceed the highest industry standards. Drawing on your expertise in regulatory compliance, you will lead the charge in establishing and maintaining robust quality management systems and be the link between different departments. This is an opportunity to be a driving force behind the integrity of our products and the continued success of our organization.
What you’ll do:
- Oversee the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with ISO 13485 and ISO27001 requirements.
- Conduct internal audits to ensure compliance and identify areas for continuous improvement.
- Manage and lead external audits from regulatory bodies and certification agencies.
- Collaborate with cross-functional teams to establish and maintain quality and regulatory processes throughout the product life cycle.
- Provide guidance on regulatory requirements and standards applicable to medical device manufacturing.
- Ensure timely and accurate submissions to regulatory authorities, including preparing and reviewing documentation for product registrations and approvals.
- Lead and support the resolution of quality issues, customer complaints, and non-conformities.
- Stay abreast of industry developments, regulatory changes, and best practices to inform decision-making.
- Managing interdisciplinary projects across departments with an impact on quality.
- Master’s degree in a relevant field (e.g., Engineering, Quality Management, Regulatory Affairs).
- Proven experience as a Quality & Compliance Manager in the medical device industry
- In-depth knowledge of ISO 13485, FDA, and other relevant regulatory requirements for medical devices
- In-depth knowledge - or willingness to dive into - ISO 27001 and related data security standards
- Strong understanding of QMS principles and practices.
- Experience in managing external audits from regulatory bodies and certification agencies.
- Excellent communication and leadership skills.
- Strong project management skills and interest to develop further into this role.
- Ability to match the requirements of quality and compliance with a fast-paced, dynamic scale-up environment.
- Excellent communication skills, both written and verbal, in English. Dutch is a plus
- Open to change and the ability to address unexpected challenges effectively
About the offer:
- Full Time or 4/5 employment in a fun, but driven team environment
- Attractive salary package, depending on experience level
- Benefits such as health insurance, meal vouchers, etc
Join us in this role to contribute to a collaborative and driven team, where your diverse skills will make a meaningful impact on our operations. This is a fantastic opportunity for an individual who thrives in a dynamic environment and is passionate about ensuring the smooth functioning of various operational aspects, from accounting to support or event management.
Minze Health is a small yet talented team, that develops impactful medical products for patients suffering from incontinence and other urological conditions. It is our daily mission to improve the quality of life of these patients with our screening and remote monitoring solutions for the patient’s condition.