Obtain, compile and prepare registration documentation, as well as document and maintain support requests for international medical device registrations received from Market Development and Corporate Brands.
Research and analyze applicable laws and regulations; develop and implement policies and procedures required to ensure the company’s ongoing compliance with international medical device registration requirements.
Maintain and update establishment licenses, device listings and reporting requirements for global markets such as Latin America (LATAM) and EMEA.
Provide guidance to Regulatory Affairs, Market Development and Corporate Brands on international product registration requirements for specific global territories.
Prepare quality metrics and provide periodic progress reports on international initiatives to internal and external stakeholders.
Support the Corporate Brands Development Group and other Business Units in research related to product registration issues.
Develop and deliver appropriate awareness and training programs for TSMs, in accordance with regulatory policies and procedures.
Participate in special projects and perform other activities as required.

Degree in Pharmaceutical Sciences, Chemistry or related fields.
Specializations in the field or industry certifications (ASQ, RAPS, ISO or equivalent) are a plus.
General knowledge of international product registration requirements for medical devices.
General knowledge of ISO 13485:2016.
General knowledge of the European Medical Device Regulation (MDR 2017/745) — desirable.
Advanced English.
Spanish is desirable.

Regulatory Affairs Analyst

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