Senior Ra Specialist

1 dia atrás

Barueri, Brasil Agilent Technologies, Inc. Tempo inteiro

The position helps to ensure products are received, licensed, and delivered by Agilent are performed in accordance with Brazil regulatory and quality standards and regulations. As a member of the Agilent Global Regulatory Team, you will provide support to business teams for IVD registrations in Latin America such as the following:
Develops and implements programs and processes to ensure that company products are safe, legal, and meet customer expectations for compliance with national/regional/global regulations.

Prepares document packages for regulatory submissions and listings to ensure alignment and compliance with local and regional registration requirements and company policies.

Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) and anticipate, assess, and communicate changes.

Compile materials required in submissions, license renewal and annual registrations.

Leads regulatory projects requiring coordination with other functions, third parties

Provide proper regulatory advice to main stakeholders considering business needs.

Monitor regulations and changes in the regulatory environment and participate on discussions related to regulation changes (Trade Associations, ANVISA) to keep internal stakeholders updated on potential risks and opportunities that could impact ongoing and future projects.

Review and approve promotional and non-promotional materials according with local regulations and Agilent procedures.

Agilent is seeking a highly skilled, motivated and customer focused professional to join our Brazil team.

**Key Responsibilities**
- Register IVD and CDx submissions with local authorities.
- Coordinate preparation of product documentation needed for obtaining Brazil regulatory permits, licenses, and registrations.
- Maintain Brazil QMS is aligned with Agilent QMS.
- Monitor for new regulations.
- Maintain and track product compliance documentation on regulated products.
- Bachelor’s degree in Pharmaceutical Sciences.
- A minimum of 8 years of relevant experience in regulated environment.
- Experience with audits from regulatory authorities and notified bodies.
- Professional registration with CRF (Regional Council of Pharmacy.
- Knowledge and experience with Brazil IVD regulatory standards and compliance requirements.
- Demonstrated teamwork skills and ability to lead, collaborate and work effectively in teams across different businesses, functions, and geographies.
- QMS experience for medical devices industry.
- Advanced written/spoken communication in English.
- Experience working with global resources across several departments or functions.
- Position is based in Sao Paulo, Brazil.

Preferred Qualifications
- Working knowledge of design controls and knowledge of applicable standards (ISO 13485 and 14791).
- Experience working with regulated products; knowledge of ISO Quality standards and Brazil medical device regulations.
- Excellent communication, strong project management and presentation skills.

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