Senior Design Control Lead – 11347

Veritaz is a leading IT staffing solutions provider in Sweden, committed to advancing individual careers and aiding employers in securing the perfect talent fit. With a proven track record of successful partnerships with top companies, we have rapidly grown our presence in the USA, Europe, and Sweden as a dependable and trusted resource within the IT industry.
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.