Senior Regulatory Affairs Lead – MedTech Scale-Up

MEQU Warmer Systems Corp.; København; Presencial; DKK 650.000 - 950.000; Jornada completa

Descripción de la vacante

MEQU Warmer Systems Corp. in Copenhagen is seeking a Senior Regulatory Affairs Specialist to join the growing QA & RA Department. You will lead regulatory activities for medical devices, shape regulatory strategy, and ensure compliance across markets.

You will collaborate with RA/QA, R&D, Operations, Sales and Marketing while driving process improvements and training the organization in regulatory matters. The role supports expansion into new markets and ongoing product development.

Formación

• Several years of experience in regulatory affairs for medical devices.
• Experience with regulatory requirements for medical device development.
• Ability to work independently with deadlines and changes.

Responsabilidades

• Vigilance process with Sales, R&D, QA to assess complaints and report to authorities.
• RA partner for Design Control and Design Change projects; define regulatory strategy and ensure documentation.
• Support electronic document management system for RA processes.
• Update and maintain quality documentation; drive continuous process improvement.
• Monitor external regulatory requirements and implement across processes/products with stakeholders.
• Train MEQU organization on general and specific RA processes.
• Assist entering new markets; drive market approval processes with local experts.
• Support Master data uploads to FDA GUDID and EU EUDAMED.

Educación

MSc in Engineering

Descripción del empleo

MEQU Warmer Systems Corp. in Copenhagen is seeking a Senior Regulatory Affairs Specialist to join the growing QA & RA Department. You will lead regulatory activities for medical devices, shape regulatory strategy, and ensure compliance across markets.

You will collaborate with RA/QA, R&D, Operations, Sales and Marketing while driving process improvements and training the organization in regulatory matters. The role supports expansion into new markets and ongoing product development.