Job Summary

Global MNC Tech is seeking a highly skilled Regulatory Affairs Linguist to support our MedTech division. This fully remote position focuses on translating and localizing regulatory documentation from English to Portuguese (PT), ensuring accuracy, compliance, and clarity for submission to regulatory authorities. The ideal candidate combines expertise in medical and regulatory terminology with exceptional language proficiency, attention to detail, and an understanding of global MedTech compliance standards. This role is key in supporting product approvals, compliance, and market readiness.

Key Responsibilities

• Translate and localize regulatory documents, including technical files, labeling, instructions for use, clinical study reports, and submission dossiers from English to Portuguese.

• Review translations for regulatory accuracy, consistency, and adherence to corporate and industry standards.

• Collaborate closely with Regulatory Affairs, Quality Assurance, and Clinical teams to ensure documentation meets local and international regulatory requirements.

• Maintain a comprehensive glossary of MedTech terminology and regulatory references.

• Assist in the preparation of submission-ready documents for regulatory authorities in Portuguese-speaking markets.

• Provide linguistic support during audits, inspections, and regulatory communications.

• Ensure timelines are met for translation and review cycles while maintaining high-quality standards.

Required Skills and Qualifications

• Native-level proficiency in Portuguese and advanced proficiency in English.

• Strong understanding of medical, technical, and regulatory terminology in the MedTech industry.

• Knowledge of ISO 13485, MDR, IVDR, FDA, and other relevant regulatory frameworks is highly desirable.

• Exceptional attention to detail, accuracy, and consistency in translation and documentation.

• Excellent communication and collaboration skills for working with cross-functional global teams.

• Familiarity with translation tools (e.g., SDL Trados, MemoQ, or similar) is an advantage.

Experience

• Minimum 3–5 years of experience in medical translation or regulatory documentation for the MedTech or Life Sciences sector.

• Prior experience working with regulatory submissions, technical files, or clinical documentation is highly preferred.

Working Hours

• Fully remote role with flexibility; core hours may align with European or LATAM time zones depending on project needs.

• Occasional urgent deadlines may require short-term adjustment of working hours.

Knowledge, Skills, and Abilities

• In-depth understanding of regulatory requirements and submission processes in Portuguese-speaking markets.

• Strong organizational skills and ability to manage multiple projects simultaneously.

• Ability to work independently and proactively with minimal supervision.

• Excellent research skills to clarify technical terminology and regulatory nuances.

• High ethical standards and confidentiality regarding sensitive regulatory documentation.

Benefits

• Competitive salary and performance-based incentives.

• Fully remote work with flexible schedule options.

• Professional development and continuous learning opportunities.

• Access to global projects and exposure to international regulatory standards.

• Health and wellness benefits, including insurance coverage where applicable.

Why Join

Global MNC Tech is a world leader in MedTech innovation, committed to improving healthcare outcomes globally. By joining our team, you will contribute to life-changing medical solutions while working in a collaborative, diverse, and inclusive environment. This role provides an opportunity to enhance your regulatory expertise, linguistic skills, and professional growth on an international scale.

How to Apply

Interested candidates should submit:

1. An updated CV/Resume highlighting relevant regulatory and translation experience.

2. A cover letter detailing experience in MedTech translation and regulatory affairs.

3. Optional samples of previous regulatory or medical translations (English > Portuguese).

Applications can be submitted through our careers portal or emailed directly to us. Shortlisted candidates will be contacted for interviews and a translation assessment.