QA/RA Manager

Join Detact Diagnostics as a Quality Assurance and Regulatory Affairs Manager, where you'll play a key role in driving the successful delivery of multiple disruptive in vitro diagnostic assays and medical device product development projects. Based on-site both at our state-of-the-art facilities at Zernike Campus Groningen and our office in the city centre of Groningen (hybrid possible), you'll be managing and operating our electronic Quality Management System, and you'll be the key person to develop regulatory strategies for our innovative products. We're looking for someone with a hands-on mentality, ready to actively engage with the team, tackle challenges head-on, and ensure adherence to international (and local) standards while collaborating closely with the entire team to effectively manage critical quality and regulatory activities.

Key Responsibilities

• Manage and operate the Quality Management System to maintain the ISO 13485:2016 certification for the design and development of our products. This includes adherence to ISO 14971:2019 and 21 CFR Part 820.
• Ensure effective implementation of QMS processes, including document control, CAPA, non-conformance management, change control and management review.
• Support the creation of technical documentation during the product development phases of our IVD products.
• Ownership of the product risk management process.
• Responsible for developing and shaping regulatory strategy and ensuring alignment with the organization's goals. Provide strategic leadership, make critical decisions, and drive the successful implementation of the strategy while monitoring its progress and adapting as needed.
• Use your expertise to manage areas of regulatory ambiguity that provide the most favourable outcome for the organization while considering risk/reward situations.
• Develop and update departmental procedures aligned with document control standards, ensuring all documentation is current and compliant.
• Translate regulatory requirements into actionable submission plans and manage submission timelines.

Your Profile

Education: Bachelor's or Master's life science degree or equivalent experience required

Experience:

o Minimum of 5 years of professional experience in a similar role

o Solid understanding of ISO 13485 standard

o Experience with EU and/or US registration procedures

o Affinity with regulatory clearance of products

o Excellent analytical, critical thinking, and interpersonal skills

o Strong organizational and problem-solving abilities

o Fluency in English (written and spoken)

Why Join Us?

Detact Diagnostics is a young, growing and ambitious Dutch company. With multidisciplinary expertise, we work together to bring the first innovative IVD products to market, and we have the ambition to broaden our VIPER® platform. With opportunities for growth and collaboration on groundbreaking initiatives, this role is perfect for a motivated, hands-on individual ready to take on a challenge.

Application

Interested? We'd love to hear from you! Send your CV and a short cover letter explaining why you're the perfect fit for this role to hr@detactdiagnostics.com.

Join us in advancing the future of diagnostics!