Regulatory Affairs Specialist

4 semanas atrás

Santo André, São Paulo, Brasil Ansell Tempo inteiro

About this Opportunity

We are seeking a highly skilled Regulatory Affairs Specialist to join our team in Santo André, Brazil. As a key member of our Regulatory Affairs department, you will play a critical role in ensuring compliance with regulatory requirements for medical devices in Brazil.

Key Responsibilities

• Preparation and maintenance of regulatory submission dossiers for Brazil compliance certifications for Medical related products in coordination with the Sr Manager RA.

• Support to ensure accurate, complete, and timely submissions to regulatory agencies

• Gathering necessary documents from each department, in coordination with the Sr Manager Regulatory Affairs.

• Liaise with Regulatory Authorities for any follow up requirements regarding regulatory submissions

• Assisting with Regulatory Authority Visits and External Notified Body audits

• 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.

• Work in collaboration with Product Management, R&D, Legal and QARA management teams to facilitate appropriate regulatory actions throughout the product life cycle

Requirements

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

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

• Understanding of local Medical regulations as applicable to Ansell's business

• Understanding of products standards

• Exposure to Quality Assurance methodologies

What We Offer

• Competitive compensation plan, base salary, and annual incentive

• Health Benefits: medical, dental and wellness programs

• Collaborative and Innovative work environment

Equal Opportunity Employer

Ansell is an equal opportunity employer and welcomes applications from diverse candidates. We are committed to creating a workplace that is inclusive and respectful of all employees.

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