About MedicQuant
MedicQuant is an innovative startup developing proprietary in vitro diagnostic (IVD) solutions for rapid point-of-care diagnostics in acute care enabling faster lifesaving treatment. We are expanding our team of passionate experts to drive product development from concept to commercialization.
Role Overview
As QA/RA Director, you will have overall responsibility for MedicQuant’s Quality Management System and regulatory compliance. You will play a key role in shaping our quality culture, ensuring efficient development processes, and guiding regulatory submissions. This is a position where you will collaborate closely with the management, development team and suppliers. Manufacturing is outsourced to specialized European suppliers; therefore, supplier oversight and quality agreements are an important part of the job.
Key Responsibilities
- Serve as Person Responsible for Regulatory Compliance (PRRC) under IVDR.
- Establish and maintain an ISO 13485 Quality Management System.
- Define and implement regulatory strategy for new products and market entry.
- Ensure efficient development processes in collaboration with the development team.
- Perform internal audits, supplier audits, and manage quality agreements with manufacturing partners.
- Lead clinical performance evaluation activities, including planning and oversight of clinical activities and Post-Market Surveillance (PMS).
- Prepare, maintain, and submit technical documentation to regulatory authorities and interaction with Notified Bodies for conformity assessment.
- Drive a quality-first culture across the organization through training and leadership.
Qualifications
- Minimum 4 years of experience with MDR/IVDR regulations.
- Proven track record in Quality Assurance and Regulatory Affairs within the medical device industry.
- Strong knowledge of ISO 13485 and quality system implementation.
- Experience with clinical evaluation processes and regulatory submissions.
- Experience with in-vitro diagnostics is an advantage but not required.
- Excellent leadership, communication, and problem-solving skills.
What We Offer
- A pivotal role in shaping MedicQuant’s compliance and quality strategy.
- Opportunity to influence the company’s regulatory roadmap and product development.
- Collaboration with external regulatory consultants for specialized expertise.
- Dynamic, innovative environment with room for professional growth, in an international setting.
How to Apply
Send your CV and cover letter to hire@medicquant.com with the subject line: QA/RA Director Application.
