Regulatory Compliance Analyst Analista de Assuntos Regulatórios

**Regulatory Compliance Analyst | Analista de Assuntos Regulatórios** **-** **(** **)**
**Description**
**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
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 B

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