Regulatory Compliance Specialist
vor 4 Wochen
BIOTYPE GmbH is at the forefront of developing, manufacturing, and distributing molecular diagnostic solutions aimed at the detection and quantification of RNA and DNA markers. Our assays play a crucial role in diagnosing and treating conditions in oncology, hemato-oncology, and forensic DNA analysis. Beyond our commercial kits, we specialize in custom assay development and manufacturing tailored for molecular diagnostics, utilizing both our proprietary MODAPLEX System and various established platforms in the industry. We engage in comprehensive product development projects, spanning from prototypes to RUO and CE-IVD stages. Our mission is to equip laboratories, pharmaceutical firms, and diagnostic companies with reliable and robust molecular genetic testing systems.
What We Offer
- Become part of an innovative organization that fosters an open and family-friendly corporate culture, promoting a collegial work environment.
- Engage in exciting and diverse responsibilities that allow for initiative, creativity, and independent work.
- We provide an unlimited employment contract, flexible working hours, 30 days of vacation, training opportunities, and additional perks such as free parking, job tickets, a company pension plan, remote work options, and lunch subsidies.
- Ensure adherence to relevant regulatory requirements and standards, focusing on EU Regulation 2017/746 for IVD.
- Contribute to the review, creation, and updating of CE-IVD Technical Documentation.
- Draft, review, and manage regulatory documentation for medical device approvals in both German and English.
- Coordinate and execute product registrations globally in collaboration with relevant departments.
- Stay informed about changes or updates to regulations, standards, and guidelines affecting medical devices.
- Implement our Post Market Surveillance process and develop and manage RA-relevant SOPs while tracking CAPA cases within the Regulatory Affairs department.
- Assist in the execution of certification and surveillance audits.
- A completed university degree or equivalent qualification.
- In-depth knowledge of relevant regulatory norms, guidelines, and laws.
- A minimum of 4 years of professional experience in the regulatory domain.
- Experience in the approval and lifecycle management of IVD software products, instruments, and systems.
- Proficient in both German and English, with strong writing and speaking skills.
- Skilled in MS Office, Adobe Acrobat, and internet research tools.
- Ability to work independently, meticulously, and in a well-structured manner, especially under time constraints.
- A quick learner, adaptable, resilient, and committed to ongoing training.
Our job offer for the Regulatory Affairs Manager (m/f/d) presents an exciting opportunity.
Submit your application through our partner Workwise in just a few minutes, with no cover letter required. You can also track the status of your application in real-time. We look forward to receiving your application through Workwise.
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