Quality and Regulatory Manager

We are looking for you! We're hiring a Quality Manager with a passion for consulting to join our Quality and Regulatory Affairs team and gain exposure to our diverse projects.

Skills and experience you can bring to this role! Qualifications and experience:

• 3+ years experience in quality management (ISO 13485 or ISO 9001);
• Proven track record working in a quality manager or regulatory affairs positions;
• Have a good understanding of ISO 13485 and ISO 14971;
• Understanding of Software as a Medical Device (SaMD), including lifecycle processes, documentation, and validation;
• Knowledge of emerging AI regulatory frameworks and ethical considerations;
• Business fluency in English (both spoken and written);
• Excellent communication, organizational, leadership and interpersonal skills;
• Enthusiastic, goal-oriented and problem-solving attitude.

Added advantages:

• Understanding of the IEC 62304 standard and the software development life cycle;
• Experience in MDR and IVDR regulations (EU);
• Understanding of ISO 27001 standard;
• Understanding of the FDA requirements.

What Impact You’ll Make

• Work in a small team of experienced regulatory enthusiasts to innovate, share experience and continuously raise our quality bar;
• Establishment, implementation and management of the ISO13485 compliant quality management system(s) (QMS) for our clients;
• Act as the management representative with notified bodies and market regulators;
• Coordinating activities related to the QMS;
• Supporting the engineering and service provision team in the development and delivery of safe medical devices;
• Defining and executing regulatory strategies for medical device-type products (mostly software as a medical device);
• Supporting product teams in the preparation of technical documentation for medical devices and the market approval process;
• Communicating, educating and building awareness about the QMS in the organization;
• Conducting audits and supporting the organization’s efforts to achieve quality goals;
• Continuously improving the QMS definition in the organization.

What You’ll Get Regardless of your position or role, we have in place a wide array of benefits including flexible working (hybrid/remote models) and generous time off policies to make it easier for all people to thrive and succeed at Star. On top of that, we offer an extensive rewarding and compensation package, intellectually and creatively stimulating space and some more.

Your holistic wellbeing is central at Star. You'll join a warm and vibrant multinational environment filled with impactful projects, career development opportunities, mentorship and training programs, fun sports activities, workshops, networking and outdoor meet-ups.