Regulatory Affairs Specialist

Há 1 mês

Santo André, São Paulo, Brasil Ansell Tempo inteiro

About Ansell

Ansell is a leading global provider of protection solutions, designing, developing, and manufacturing a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries.

Our Purpose

At Ansell, our purpose is protection. We believe in protecting people and the planet through innovation and sustainability.

Job Summary

We are seeking a Regulatory Affairs Specialist to join our team in Santo André, Brazil. This role will provide support in the development and management of regulatory dossiers for submission to regulatory authorities to ensure regulatory certifications, specifically for Brazil.

Key Responsibilities

  1. Preparation and maintenance of regulatory submission dossiers for Brazil compliance certifications for medical-related products in coordination with the Sr Manager RA.
  2. Support to ensure accurate, complete, and timely submissions to regulatory agencies.
  3. Gathering necessary documents from each department, in coordination with the Sr Manager Regulatory Affairs.
  4. Liaise with Regulatory Authorities for any follow-up requirements regarding regulatory submissions.
  5. Assisting with Regulatory Authority Visits and External Notified Body audits.
  6. Post-Market Surveillance – facilitate import/export regulatory activities for Ansell Products to ensure compliance with government regulations as well as coordinate recalls and detentions as required.
  7. Work in collaboration with Product Management, R&D, Legal, and QARA management teams to facilitate appropriate regulatory actions throughout the product life cycle.
  8. Continually appraise the Regulatory Affairs department of matters of importance in the incumbent's area of responsibility that impact on the business, or which is necessary to meet the required objectives.
  9. Provide Customer support for regulatory-related information, including compliance or clearance-related information.
  10. Work with the Sr Manager RA to provide regulatory assessment reviews and approvals as an input to overall business planning/strategies throughout the product lifecycle.
  11. Provide the required regulatory support towards the RA employees in the Americas Region in the execution of the relevant Medical certification process.
  12. Maintenance of the Global Regulatory Affairs databases & similar systems used by Global Regulatory Affairs, such as the website, Asset Bank, Trackwise, etc.
  13. Supports quality initiatives in creating quality plans, meaningful metrics, and procedures in accordance with regulatory authority requirements.
  14. Collaborates with multiple business unit and regional teams to formulate procedures, assist in projects, and provide input to the quality management system.
  15. Other relevant Regulatory Affairs duties, as required.

Requirements

Education: Associates or Bachelor's Degree in a relevant scientific/technical field (pharmacy, chemistry, chemical engineering, etc.).

Job Experience: Preferably, minimum 2 years in a Regulatory Affairs environment within pharmaceutical, cosmetics, and/or medical devices. Medical Devices preferred.

Knowledge and Skills: Understanding of local Medical regulations as applicable to Ansell's business, understanding of products standards, exposure to Quality Assurance methodologies, strong PC literacy.

What We Offer

Ansell offers a competitive compensation plan, base salary, and annual incentive, health benefits (medical, dental, and wellness programs), and a collaborative and innovative work environment.

Equal Opportunity Employer

Ansell values diversity and understands that what adds up is precisely varied ideas and points of view. Therefore, race, color, religion, creed, national origin, sex, and gender identity, nationality, disability or mental disability, sexual orientation, ancestry, or age will not prevent you from being part of our team.

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