QA/RA Manager

Rotterdam Innovation City; Rotterdam; Hybrid; EUR 90,000 - 130,000; Full time

Benefits offered by this job

Hybrid work model

Competitive salary

Opportunities for personal growth

Life sciences career at innovative bi

Societal impact

Job summary

SkylineDx is seeking a QA/RA Manager to promote the quality management system and regulatory compliance across the organization. You will lead the QA/RA team and collaborate with senior management to integrate QA/RA aspects into company strategy, ensuring adherence to IVDR and ISO 13485 standards.

The role is based in Rotterdam with a hybrid work model. You will drive change control, document control, audits, CAPA, and regulatory submissions while ensuring readiness for market releases and

Qualifications

• Master’s degree in life science or business-related topics.
• 5+ years QA/RA experience in medical device/IVD industry.
• Strong knowledge of EU IVDR (2017/746) and ISO 13485.

Responsibilities

• Translate company strategy into QA/RA roadmap, priorities, and team objectives.
• Lead and manage QA/RA team, ensuring effective execution of activities.
• Maintain the Quality Management System including change control, document control, non-conformances, audits, risk management, and continuous improvement.
• Serve as SME on IVDR, ISO 13485 and other standards.
• Oversee preparation and approval of quality, technical documentation, and validation docs.
• Primary liaison with regulatory authorities for IVD compliance, inspections, submissions.
• Plan and oversee internal and supplier audits with proper follow-up.
• Coordinate and deliver QA/RA training across the organization.
• Ensure products meet regulatory requirements prior to market release.

Job description

QA/RA Manager at SkylineDx

Your job in a nutshell

As a QA/RA Manager, you will promote awareness throughout the company of the quality management system, including regulatory requirements, in support of the company goals. You will assure compliance with regulatory and quality standards of the products and services of SkylineDx, contribute to discussions with senior management about the strategy of the company, ensuring QA/RA-aspects are taken into account. You will lead the QA/RA team in maintaining and updating the quality management system.

Together we ensure the validation and implementation of clinically relevant scientific discoveries into reliable medical diagnostic assays for diagnosis, prognosis and drug effectiveness prediction that will ultimately contribute to improved patient care.

You will work from our Rotterdam office (hybrid work model) and report to the QA/RA Director.

Essential Duties and Responsibilities

• Translate company strategy into a clear QA/RA roadmap, priorities, and team objectives.
• Lead and manage the QA/RA team, ensuring effective execution of quality and regulatory activities.
• Hold overall responsibility for the Quality Management System, including change control, document control, non-conformances, audits, risk management, and continuous improvement.
• Serve as subject matter expert on IVDR, ISO 13485, and other applicable quality and regulatory standards.
• Oversee the preparation, review, approval, and implementation of quality procedures, technical documentation, and validation documentation.
• Act as the primary liaison with regulatory authorities for IVD compliance, inspections, and regulatory submissions.
• Plan and oversee internal and supplier audits and ensure appropriate follow-up.
• Coordinate and deliver quality and regulatory training across the organization.
• Ensure products meet applicable quality and regulatory requirements prior to market release.

You have

• a Master’s degree in life science or business-related topics.
• 5+ years of QA/RA experience within the medical device or IVD industry.
• strong knowledge of EU IVDR (2017/746) and ISO 13485 requirements.
• hands-on experience with Quality Management Systems, including document control, audits, non-conformances, CAPA, and change control.
• experience preparing, reviewing, and approving quality, design & development, and technical documentation.
• proven experience coordinating quality/regulatory projects and managing timelines.
• experience interacting with Health Authorities and Notified Bodies.
• team management experience (pre).
• knowledge of FDA requirements and guidance for IVD product development (pre).
• experience evaluating laboratory test results (pre).
• knowledge of ISO 15189 and medical laboratory requirements (pre).
• a hands-on mentality and result oriented attitude.
• the ability to Influence at all levels of the organization.
• strong communication, supervision, and delegation skills.
• an excellent command in written and spoken English.

We offer

• a full-time position, a market competitive salary and market competitive secondary conditions of employment.
• a hybrid work model.
• opportunities for personal growth.
• the best of two worlds: a career in life sciences at an innovative biotech company with the emphasis on clinical diagnostics in close collaboration with an academic environment.
• the ability to serve society with science-based solutions.

At SkylineDx

We live to make a difference. It is our mission to improve a patient’s quality of life by enabling them to benefit from personal insights at the genomic level of their disease. That means we are continuously innovating the world of gene signature-based diagnostic testing. That also means we have a unique blend of characteristics. We have our soft side. Our culture is oftentimes described as familial, warm, loyal and highly engaged. We have our rational side where exact sciences are driving our mission, and when needed our passionate side surfaces to clear the way so we can serve society with science-based solutions.

At SkylineDx, we are committed to creating an inclusive workplace where everyone is treated with respect and given equal opportunities. We welcome applications from all qualified candidates, regardless of gender, age, race, ethnicity, religion, disability, sexual orientation, gender identity or expression, or any other characteristic protected by applicable law.