Regulatory Affairs Specialist - Medical Devices

Join knok in revolutionising healthcare and making a tangible impact on people's lives by working as a Regulatory Affairs Specialist - Medical Devices. The role involves managing regulatory processes for medical devices, preparing technical documentation, and ensuring compliance with regulatory requirements.

Requirements

• 3 to 5 years of experience in regulatory affairs for medical devices
• Proven experience in certification processes (e.g. CE marking under MDR)
• Solid knowledge of quality management systems (e.g. ISO 13485)
• Experience in preparing technical documentation (Technical File / Design Dossier)
• Ability to work both independently and within a multidisciplinary team
• Fluency in Portuguese and English (mandatory)

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship