Regulatory Compliance Manager
vor 3 Wochen
BIOTYPE GmbH specializes in the development, production, and distribution of molecular diagnostic kits and systems designed for the detection and quantification of RNA and DNA markers. Our assays play a crucial role in the diagnosis and treatment within oncology, hemato-oncology, and forensic DNA analysis. Alongside our commercial kits, we provide tailored assay development and manufacturing services for molecular diagnostics, applicable to both our proprietary MODAPLEX System and various established platforms in the industry. We engage in projects across all phases of product development, from prototype to RUO to CE-IVD, aiming to deliver secure and robust molecular genetic testing systems to laboratories, pharmaceutical, and diagnostic companies.
What We Offer
- Become part of an innovative organization that fosters an open and family-friendly corporate culture with a supportive 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 ticket, company pension plan, remote work options, and lunch subsidies.
- Ensure adherence to applicable regulatory standards and requirements, 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 necessary for the approval of medical devices in both German and English.
- Plan and execute product registrations globally in collaboration with relevant departments.
- Stay informed about changes or updates to regulations, standards, and guidelines pertaining to 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 legislation.
- A minimum of 4 years of professional experience in the regulatory sector.
- 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, particularly under time constraints.
- A quick learner who is adaptable, resilient, and open to ongoing training.
Are you interested in the position of Regulatory Affairs Manager (m/f/d)?
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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