Regulatory Compliance Analyst %7C Analista de Assuntos Regulatórios

Ansell; Santo André; Presencial; BRL 60.000 - 90.000; Tempo integral

Resumo da oferta

A global protection solutions provider is seeking a Regulatory Affairs Specialist in Santo André, Brazil. This role requires at least 2 years of experience in regulatory affairs, focusing on medical devices compliance. Candidates should possess a relevant degree and have strong problem-solving skills. The position offers competitive compensation, health benefits, and a collaborative work environment.

Serviços

Competitive compensation plan

Health Benefits

Collaborative work environment

Qualificações

• Minimum 2 years in a Regulatory Affairs environment.
• Exposure to Quality Assurance methodologies.
• Understanding of products standards.

Responsabilidades

• Preparation and maintenance of regulatory submission dossiers.
• Liaise with Regulatory Authorities for submissions.
• Support regulatory assessments and approvals.

Conhecimentos

Understanding of local Medical regulations

Strong PC literacy

Collaboration and teamwork

Problem solving

Good communication skills

Formação académica

Associates or Bachelor’s Degree in a relevant scientific/technical field

Descrição da oferta de emprego

Why Ansell

Ansell is a leading global provider of protection solutions. Our company designs, develops and manufactures a wide range of protection solutions that meet the ever-changing needs and demands of our markets and industries. Protection is our primary concern as millions of people around the world depend on Ansell in their professional and personal lives.

Why we do it

Safety culture is what we believe in! Protecting people and Protecting the planet through innovation and sustainability is what we are passionate about. Ansell’s purpose is protection! Come join a trusted market leader!

Ansell is looking for a Regulatory Affairs Specialist to join our team in Santo André, Brazil!

About this opportunity

Role Profile

Position Title: RA Specialist

Job Location: Santo André, Brasil

Job Type: Full-Time

Status: Exempt

Reports to SR Manager, RA – Medical Products

Specific responsibilities include:

This position reports to the SR Manager Regulatory Affairs and provides support in the development and management of regulatory dossiers for submission to the Regulatory Authorities to ensure regulatory certifications, specifically for Brazil.
The function will also work with the Regulatory Affairs Managers/Specialists , LAC in helping them to execute the Medical Device certification process. In addition, this position is responsible for providing cross functional support for quality management systems to comply with Brazil regulatory requirements for medical devices. These activities include but are not limited to procedure development, corrective and preventive action investigations, data analysis/trending, and other internal projects as they relate to the quality system. This position will also support common quality system functions as needed, such as internal and external audits.

What would this role look like in detail?

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 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 Ansell.com 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 in order to formulate procedures, assist is projects and provide input to the quality management system.

15. Other relevant Regulatory Affairs Duties, as required

What will you bring to Ansell?

Education

Associates or Bachelor’s Degree in a relevant scientific/technical field e.g. 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

Other relevant experience and specialized training will be considered.

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

Desirable Job Competencies

Positive, “can do”, flexible attitude.

Collaboration and teamwork when working with key partners

Problem solver to assist the business in ensuring regulatory compliance

Team player

Results Oriented

Good communication and interpersonal skills

What will you get from Ansell?

· Competitive compensation plan, base salary, and annual incentive

· Health Benefits: medical, dental and wellness programs

· Collaborative and Innovative work environment

Equal Opportunity Employer

️ At Ansell we value diversity and understand 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.

The information collected by this application is solely to determine suitability for employment, verify identity, and maintain employment statistics on applicants.

Our Commitment to Diversity Equity and Inclusion

Ansell’s vision is about creating safe spaces where diverse perspectives are valued alongside individual contributions. It is our view that togetherness prevails over individuality.

When we say that everyone deserves to belong, feel included and empowered at work, it's not just words. Rather, it’s what drives Ansell as an organization towards a workforce that reflects the diversity of our community, it’s what drives us to serve our customers and stakeholders with pride, and it’s also what differentiates Ansell. We believe everyone, no matter how that person self-identifies, deserves an opportunity to achieve success.