Design Control Specialist

About the role

LiNA Medical is looking for a Design Control Specialist in Copenhagen with an engineering or similarly relevant background. The role sits at the interface of RA, R&D and QA, focusing on design control compliance in projects, while also covering CAPA support, new standards and active participation in audits. The position is full-time (37 hours per week) and is now closed.

Key responsibilities

• Ensure the quality of project documentation, with a focus on compliance with external regulatory requirements
• Prepare design control documentation for new projects and drive your own tasks alongside the Project Manager
• Help align the team on creating the technical file and keep development procedures up to date
• Handle risk management, including ISO 14971, and prepare test protocols and reports for verification and validation when needed
• Complete documentation needed to obtain approvals for marketing new products
• Take part in testing finished products and prototypes, and maintain the QMS through audits and corrections

Required profile

• Engineering degree or similar technical background
• Solid experience in MedTech and in design control within projects (R&D or RA)
• Thorough knowledge of the new MDR, ISO 13485 and FDA 21 CFR 820
• Experience with design control is required; experience with risk management, design input/output and V&V, clinical evaluation and document control is an advantage
• Structured, proactive and able to take the lead in a project team
• English at a level that allows clear communication with all stakeholders; Danish or other languages are a bonus

Required skills

• Knowledge of ISO 13485, FDA 21 CFR 820 and ISO 14971
• Comfortable with MS Office (Word, Excel, PowerPoint)
• Experience with other IT systems for documentation and planning

What we offer

• Attractive fixed monthly salary, pension and health insurance
• PC, phone and internet, optional lunch plan
• 5 weeks annual leave plus 5 individual days
• Flexible travel of 5-20 days per year
• International workplace with a strong link to the Polish production site