Assignment Description:

We are looking for a Senior Design Control Lead to join our dynamic team.

What you will work on:

• Independently apply design control processes to pipeline projects, ensuring compliance with regulatory requirements.
• Oversee the interfaces between design control and risk management activities, ensuring seamless integration.
• Support continuous improvement initiatives led by the Project Management Excellence Team.
• Create, update, and manage design control documentation, including design and development plans, input requirements, traceability matrices, verification and validation reports, and design transfer documents.
• Coordinate and facilitate cross-functional team meetings, ensuring alignment across early development, late development, filing, and launch phases.
• Participate in risk management activities in accordance with ISO 14971, identifying and mitigating risks.
• Act as an independent reviewer for design reviews and provide expert guidance during audits, inspections, and authority inquiries.
• Collaborate with stakeholders to explain policies, practices, and procedures related to design control and device development.
• Support project teams across functions such as R&D CMC, Pre-clinical, Clinical, Global Regulatory Affairs, and others with design control expertise.

What you bring:

• 5–7 years of experience in device design control within the life science industry.
• Proven expertise in design control for devices, complying with regulations such as EU MDR 2017/745 and 21 CFR 820.30.
• Strong knowledge of GMP and Quality Management Systems, including ISO 13485.
• Familiarity with risk management standards (ISO 14971/ISO 24971) and usability engineering (IEC 62366) for medical devices.
• Experience in device development and leading cross-functional teams spanning Pre-Clinical, CMC, Clinical, Manufacturing, Regulatory, Quality, and Commercial functions.
• Ability to act as a subject matter expert during audits, inspections, and regulatory inquiries.
• Exceptional communication and facilitation skills to coordinate cross-functional teams and stakeholder interactions.
• Fluent in English and Swedish.

If this sounds interesting, please send your CV to cv@veritaz.se