Job Summary

Global MNC Tech is seeking a highly detail-oriented and experienced Regulatory Affairs Linguist to support our growing MedTech portfolio. In this fully remote role, you will be responsible for translating, localizing, and linguistically validating regulatory and clinical documentation from English into Portuguese, ensuring full compliance with global regulatory standards.

You will collaborate closely with regulatory, clinical, and quality teams to ensure accuracy, consistency, and regulatory readiness of multilingual submissions. This position is ideal for a linguist with strong MedTech knowledge who thrives in a fast-paced, quality-driven environment.

Key Responsibilities

• Translate and review regulatory, clinical, and technical MedTech documents from English into Portuguese.

• Ensure linguistic accuracy, regulatory compliance, and adherence to client terminology and style guides.

• Perform linguistic quality assurance (LQA) and terminology management.

• Collaborate with Regulatory Affairs, Quality Assurance, and Clinical teams to support submission readiness.

• Maintain consistency across product labeling, IFUs (Instructions for Use), clinical evaluation reports, and regulatory dossiers.

• Support localization workflows and contribute to process improvements.

• Manage multiple projects simultaneously while meeting strict deadlines.

• Stay current with evolving regulatory language requirements in target markets.

Required Skills and Qualifications

• Native or near-native proficiency in Portuguese with excellent command of English.

• Proven expertise in medical device or MedTech regulatory translation.

• Strong understanding of regulatory documentation standards (e.g., IFU, CER, technical files).

• Exceptional attention to detail and linguistic precision.

• Proficiency with CAT tools (such as Trados, memoQ, or similar).

• Ability to work independently in a remote environment.

• Strong written communication and documentation skills.

Experience

• Minimum 3–5 years of professional translation or regulatory linguist experience in MedTech, Life Sciences, or Medical Devices.

• Demonstrated experience supporting regulatory submissions for international markets preferred.

• Experience working with global or multilingual regulatory teams is highly desirable.

Working Hours

• Fully remote position.

• Flexible working schedule with core overlap hours required with global teams.

• Ability to accommodate occasional deadline-driven workload peaks.

Knowledge, Skills and Abilities

• Solid understanding of medical device terminology and regulatory frameworks.

• Familiarity with ISO, MDR, and other global regulatory environments is a plus.

• Strong analytical and problem-solving skills.

• High level of organizational and time-management ability.

• Ability to maintain confidentiality and handle sensitive documentation.

• Collaborative mindset with the ability to work cross-functionally.

Benefits

• Competitive compensation package.

• 100% remote work flexibility.

• Opportunity to work on cutting-edge MedTech innovations.

• Professional development and training support.

• Collaborative global work environment.

• Long-term project stability and growth opportunities.

Why Join Global MNC Tech

At Global MNC Tech, you will contribute to meaningful healthcare innovations that impact patients worldwide. We foster a culture of precision, collaboration, and continuous improvement. Joining our team means working with industry experts, expanding your regulatory expertise, and growing your career in the rapidly evolving MedTech space—all while enjoying the flexibility of remote work.

How to Apply

Interested candidates should submit their updated CV along with:

• A brief cover letter highlighting relevant MedTech regulatory linguist experience.

• Details of CAT tools proficiency.

• Availability and expected compensation.

Qualified applicants will be contacted for the next steps in the selection process.