Regulatory Affairs Manager
Join our dynamic team at kaiko.ai as a Regulatory Affairs Manager! At kaiko.ai, we share a passion for leveraging data, machine learning, and technology to enhance healthcare outcomes. As Regulatory Affairs Manager you'll play a crucial role in ensuring regulatory compliance of our software platform and AI products while contributing to the advancement of healthcare technology.
Key Responsibilities:
- Craft and Uphold Excellence: Develop and maintain our Quality Management System to ensure our products and operations meet the highest standards of quality and compliance.
- Stay Ahead of Regulatory Changes: Monitor regulatory updates, assess their impact, and proactively communicate changes to internal stakeholders to maintain our leadership in compliance.
- Identify and Address Compliance Challenges: Conduct regulatory assessments and gap analyses to identify areas of non-compliance or potential risks, then develop and execute action plans to address them effectively.
- Serve as Regulatory Liaison: You are the Person Responsible for Regulatory Compliance (PRRC), and act as the primary point of contact for regulatory agencies, notified bodies, and external stakeholders, ensuring all regulatory documentation is prepared and maintained accurately.
- Collaborate for Success: Work closely with cross-functional teams to integrate regulatory requirements seamlessly into product development and lifecycle management processes, ensuring our products meet regulatory standards from inception to launch.
You Bring
- Expertise: Master’s degree in a relevant field (e.g., Regulatory Affairs, Engineering, Life Sciences) with a minimum of 1 year of experience in regulatory affairs within the medical devices field, preferably with a focus on medical device software.
- Regulatory Know-How: Thorough understanding of regulatory requirements (MDR and IVDR) and standards (ISO 13485, ISO 14971, and ISO 62304) applicable to our industry.
- Proven Success: Demonstrated track record of managing regulatory submissions, approvals, and compliance activities.
- Project Management Prowess: Strong project management skills, including the ability to prioritize tasks, manage deadlines, and coordinate cross-functional teams effectively.
- Communication Skills: Excellent communication and interpersonal skills, with the ability to engage and influence both internal and external stakeholders.
You reside in The Netherlands and have a valid work permit. Given the nature of Kaiko’s business and the fact that we deal with sensitive data, a Certificate of Conduct will be required upon entering into an employment contract.
What can you expect?
At Kaiko we have an open, creative and non-hierarchical work atmosphere which offers continuous learning and direct impact in return for accountability and team spirit.
We offer flexibility - for instance, through remote working – alongside an expectation for managing and delivering your own goals; our team’s ownership, passion and shared commitment to improving health outcomes through data is something that sets us apart.
At the intersection of healthcare and data we recognize the implications on wellbeing and trust and approach our work with the utmost sensitivity. Data privacy, compliance and security are core to everything we do. Our open, creative environment gives talented people room to explore new ideas and we reward this with an attractive package and opportunities for further personal development.
If you're ready to take on a challenging and rewarding role in a fast-paced start-up environment, we want to hear from you! Send us your application online (www.kaiko.ai) and we will contact you as soon as possible.
At Kaiko we welcome everyone with equal enthusiasm. Should you have any questions, please do not hesitate to contact us at recruitment@kaiko.ai
- Department
- Kaiko Support Functions
- Locations
- Amsterdam (NKI-AvL)
- Remote status
- Hybrid Remote
Amsterdam (NKI-AvL)
Regulatory Affairs Manager
Loading application form
Already working at Kaiko?
Let’s recruit together and find your next colleague.