Primary Responsibilities

• Manage, write, and analyze system requirements ensuring compliance with medical device design controls and regulatory standards.
• Collaborate with cross-functional teams to define, document, and validate system requirements.
• Apply critical thinking and problem-solving skills to identify and resolve technical and process issues.
• Support risk management activities and integrate them with requirements and design controls.
• Coordinate and participate in project activities, supporting project schedules and deliverables.
• Assist in the creation and maintenance of traceability matrices to ensure comprehensive verification and validation.
• Facilitate verification and validation (V&V) processes, ensuring requirements coverage and product quality.
• Utilize tools such as IBM DOORS for requirements management and Agile project management tools.
• Communicate effectively within multidisciplinary teams and stakeholders.

Required Qualifications

• 3-5 years of experience in requirements management and requirements writing.
• Proven experience in the In Vitro Diagnostic (IVD) and medical device industry.
• Familiarity with FDA and IVDR design controls and regulatory requirements.
• Strong critical thinking and problem-solving skills.
• Collaborative and team-oriented personality with excellent communication abilities.
• Understanding of risk management processes and their integration with design controls.
• Proficiency with MS Office tools.

Preferred Qualifications

• Experience with IBM DOORS for requirements management.
• Project coordination experience.
• Experience developing and maintaining traceability matrices.
• Familiarity with verification and validation (V&V) processes.
• Experience working in Agile development environments.

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