Quality & Regulatory Affairs Manager
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Job Location:
Zürich - Switzerland
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
Tasks
Quality Management System (QMS)
Regulatory Affairs
Supplier & Customer Quality
CAPA & Change Management
Risk PMS & Vigilance
- Maintain and further develop the QMS in accordance with applicable standards and regulations.
- Ensure effective document control record maintenance and system updates.
- Prepare and maintain quality reports (e.g. Product Quality Reviews Management Review inputs).
- Support internal and external audits and follow-up on findings.
Regulatory Affairs
- Ensure regulatory compliance in applicable markets.
- Support product registrations changes and lifecycle activities.
- Monitor regulatory changes and assess impact on products and processes.
- Coordinate third-party testing activities as required.
Supplier & Customer Quality
- Lead and support supplier quality activities including qualification monitoring and nonconformities.
- Support customer quality topics such as complaints investigations and feedback evaluation.
CAPA & Change Management
- Support and manage CAPA activities including investigations root cause analysis implementation and effectiveness checks.
- Support Engineering Change Orders (ECOs) with focus on quality regulatory compliance and documentation integrity.
Risk PMS & Vigilance
- Support Post Market Surveillance activities including data collection evaluation and documentation.
- Support risk management activities according to ISO 14971.
- Ensure PMS and risk outputs are reflected in CAPA labelling and documentation.
About the position
Your key role is to maintain and continuously improve the Quality Management System and regulatory compliance of the organization. The role ensures that products processes suppliers and documentation comply with applicable regulatory requirements and standards throughout the full product lifecycle. The position combines operational quality and regulatory activities with leadership responsibility in defined areas and acts as a key interface between R&D Operations Supply Chain and external stakeholders. Do you want to help us to make lung function testing accessible to everyone everywhere and to improve the lives of millions of people with lung diseases Then you have come to the right place!
Your profile
- Bachelors or Masters degree in biomedical engineering life science discipline or comparable technical or scientific field.
- At least 5 years of professional experience in quality management quality assurance and regulatory affairs within the medical device industry.
- Proven experience with QMS audits supplier management and product development projects.
- Solid knowledge of medical device regulations and applicable standards.
- Strong understanding of Quality Management Systems risk management and product lifecycle processes.
- Structured analytical and qualityfocused working style with the ability to work independently and crossfunctionally.
- Strong communication skills and confidence in interaction with internal and external stakeholders.
- Leadership and decisionmaking capabilities within defined areas of responsibility; leadership experience in quality functions is an advantage.
- Strong knowledge of ISO 13485 QMSR ISO 14971 IEC 606011.
- Excellent knowledge of documentation and quality tools (e.g. MS Office Polarion Salesforce).
- Professional fluency in English and German; additional languages are a plus.
Why us
We offer an attractive location fair pay good social benefits flexible working hours hybrid work and the best conditions in which to do excellent work. This includes comprehensive onboarding professional and modern technology and a collegial and supportive working environment. We promote equal opportunities diversity and inclusion.
If this profile describes you and you would like to work at a fast-growing company in a global environment then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
If this profile describes you and you would like to work at a fast-growing company in a global environment then we should meet. Apply directly and exclusively via our e-recruiting tool. The more we learn about you the better. We look forward to receiving your complete application and reference letters. Your data will be treated confidentially and discreetly.
Contact
We kindly ask for direct applications only. Unsolicited dossiers from agencies will not be considered and we decline all responsibility for any fees related to such submissions.
About us
ndd Medizintechnik AG is a leading company and innovator in pulmonary function testing devices. For 30 years ndd has created solutions that improve early detection of chronic lung diseases including COPD and asthma. Today ndd offers unique spirometry and pulmonary function testing devices that are available in more than 100 countries around the globe.
Required Experience:
Manager
About Company
ndd Medizintechnik AG is a leading company and innovator in pulmonary function testing devices. For more than 25 years, ndd has created solutions that improve early detection of chronic lung diseases, including COPD and asthma. Today, ndd offers unique spirometry and pulmonary funct ... View more
