Regulatory Affairs Specialist

About the role

The Regulatory Affairs Specialist will support the LATAM RAQA manager in ensuring that all products and activities comply with Brazilian and international medical device regulations. This role combines regulatory dossier management with quality system oversight, requiring close interaction with internal teams and external authorities.

Key responsibilities

• Prepare, review and submit dossiers for product notification, registration, renewals and changes.
• Participate in new product development projects and assess technical documentation, change controls and gap analyses.
• Act as Technical Responsible Person before Brazilian authorities when required.
• Maintain and renew operating licenses, permits and approve marketing materials.
• Provide regulatory input to cross‑functional projects and monitor regulatory intelligence.
• Support quality activities such as complaints handling, non‑conformities, internal audits and alignment with ISO 13485 and MDSAP.
• Assist the RAQA analyst and serve as a focal point for technical matters.

Required profile

• Minimum 5 years of experience in Regulatory Affairs and Quality Assurance for medical devices.
• Strong knowledge of local Brazilian regulations and global standards (ISO 13485, MDSAP).
• Ability to work in an office environment and travel occasionally (<5% of time).
• Excellent written and verbal communication skills in English; basic Spanish is a plus.

Required skills

• Advanced proficiency in Microsoft Office Suite (Word, PowerPoint, Excel).