Strategic Regulatory Affairs and Quality Manager
vor 1 Tag
We are innovators, driving forces and pathway makers in the healthcare industry. Our health platform myoncare is revolutionizing the market by connecting all players to ensure patients receive the right therapy at the right time.
Our commitment is centered around people and their needs. We strive to provide excellent support for all patients worldwide by collecting clinical patient data through audited blockchain technology.
This secure and transparent approach ensures the integrity of patient care functions that were previously fragmented or incomplete. Myoncare bundles these functionalities into one application, offering a unique solution for patients and healthcare professionals alike.
We are on a mission to transform the healthcare landscape and make it more accessible and efficient. As a key member of our team, you will play a vital role in shaping this future.
Key Responsibilities- Perform gap analyses of regulatory documents and QMS documentation, identifying areas for improvement and implementing necessary adaptations.
- Ensure continuous compliance of QMS and product with evolving regulatory requirements, including laws, standards, and guidance documents.
- Develop and execute regulatory pathways for successful market access, fostering growth and innovation within the organization.
- Promote process improvements in QMS, driving efficiency and effectiveness throughout the company.
- Administer and maintain QMS documentation, guaranteeing accuracy and completeness.
- Provide expert advice to other departments on regulatory and quality-related matters, ensuring seamless collaboration and communication.
- Design and deliver employee training programs, equipping colleagues with the knowledge and skills needed to excel in their roles.
- At least two years of experience in Regulatory Affairs or Quality Department for medical devices, preferably involving medical device software.
- A minimum of two years of experience in managing QM systems covering ISO 13485.
- In-depth knowledge of MDR 2017/745, EN ISO 13485:2016, CFR part 820, and relevant sections of the FD&C Act.
- Experience in generating and adapting SOPs and Working Instructions, collaborating with departments like Research & Development and Product Management.
- Background in Regulatory Affairs for USA markets is beneficial.
- Experience in medical device vigilance is also beneficial.
- Familiarity with ISO 14971, EN 62304, and EN 62366 is advantageous.
- Demonstrated ability to work independently with a strong sense of responsibility for personal actions.
- Drive to identify opportunities for improvement and find solutions that benefit stakeholders.
- Thoroughness and attention to detail, with the capacity to adapt quickly to new challenges under tight deadlines.
- Excellent time management and organizational skills.
- Effective communication in international and interdisciplinary teams, with active listening skills.
- Fluency in English (written and spoken), with German proficiency being an asset.
- An attractive salary range of €80,000 - €120,000 per annum, depending on qualifications and experience.
- A centrally located office with plenty of lunch options.
- A personalized onboarding experience to ensure a smooth transition.
- The opportunity to collaborate with a global team shaping the future of healthcare.
- Regular team events and social activities.
- Coffee and tea stations for daily rejuvenation.
- Employee discounts and benefits.
- Networking opportunities with sister companies (sqanit & CONVIEN) for professional growth.
Contribute to the digital transformation of healthcare and join us on this visionary journey.
Become part of the ONCARE GmbH family and apply today with your complete application documents, stating your earliest possible starting date and salary expectations.
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