Jobbeschreibung
As the world's leading provider of software-based pathogen identification, Noscendo is revolutionising infectious disease diagnostics. Offering our DISQVER platform, we help physicians and microbiologists make the right decisions for critically ill patients in an actionable timeframe.
Why should you join Noscendo?
We offer a meaningful and stimulating environment allowing our multidisciplinary teams to transform science and technology into life saving diagnostics solutions.
At the interface of molecular diagnostics and bioinformatics, we are shaping the future of infectious disease diagnostics to save patient lives. In our fast-growing start-up, you benefit from flat hierarchies and development opportunities tailored to your needs. Agile working and efficient, adaptable processes instead of corporate bureaucracy, giving you the freedom to develop and implement your ideas. Here you can and should get involved.
At Noscendo, we work together in a spirit of trust, collaborating in a friendly and honest manner. We rely on flexibility and support this with family-friendly structures and optimising working conditions.
Apply now and make medical history with us!
The Junior Quality Management & Regulatory Affairs Manager (m/w/d) is responsible for ensuring that the company's products comply with all regulations and standards in the target markets.
This role involves implementing regulatory strategies, managing quality systems, and ensuring continuous compliance with regulatory requirements.
Quality Management:
- Support the development, implementation, and maintenance of the Quality Management System (QMS) in accordance with applicable standards (e.g. ISO 13485, 27001).
- Assist in conducting internal audits and support external audits and inspections.
- Help oversee corrective and preventive actions (CAPAs) and ensure timely resolution of quality issues.
- Monitor and report on key quality metrics and trends.
- Support continuous improvement initiatives and promote a culture of quality within the organization.
- Collaborate with cross-functional teams to ensure regulatory and quality requirements are integrated into product development.
- Assist in the development and delivery of training programs related to regulatory and quality compliance.
Regulatory Affairs:
- Assist in the development and implementation of regulatory strategies to ensure product approvals in target markets.
- Prepare and submit regulatory submissions.
- Maintain knowledge of regulatory requirements and ensure compliance with applicable regulations.
- Support interactions with regulatory agencies and assist in managing regulatory inspections and audits.
- Ensure timely and accurate reporting to regulatory authorities.
- Bachelor's degree in a scientific discipline (e.g. biology, chemistry, engineering). Advanced degree or additional certification in regulatory affairs or quality management is a plus.
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Minimum of 2 years of experience in regulatory affairs and/or quality management within the pharmaceutical, medical device, or biotechnology industry.
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Attention to detail to ensure accuracy and thoroughness in regulatory submissions and quality documentation.
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Effective communication of regulatory and quality information to various stakeholders.
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Decision Making: Supporting informed decision-making based on regulatory knowledge and quality principles.
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Ability to adapt to changes in regulatory and quality requirements.
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Strong analytical and problem-solving skills.
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Excellent written and verbal communication skills.
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Ability to manage multiple tasks and priorities.
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Teamwork and collaboration skills.
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English language skills necessary. German would be an advantage.
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Occasional travel may be required.
- A position in a fast-growing start-up that is expanding internationally
- The opportunity to put your own ideas into practice
- A dynamic, diverse, high-performing team that values your efforts
- 30 days vacation
- Flat hierarchies and short communication channels
- High-quality technical equipment
- Employee discounts
- Numerous other benefits