Specialist, Regulatory Compliance.Quality.Regulatory
Ansell
- Santo André - SP
- Permanente
- Período integral
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 agencies3. 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 submissions5. Assisting with Regulatory Authority Visits and External Notified Body audits6. 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 cycle8. 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 information10. 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 process12. 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 requiredWhat will you bring to Ansell?EducationAssociates or Bachelor’s Degree in a relevant scientific/technical field e.g. pharmacy, chemistry, chemical engineering etc.Job ExperiencePreferably, minimum 2 years in a Regulatory Affairs environment within pharmaceutical, cosmetics and / or medical devices. Medical Devices preferredOther relevant experience and specialized training will be considered.Knowledge and SkillsUnderstanding of local Medical regulations as applicable to Ansell’s businessUnderstanding of products standardsExposure to Quality Assurance methodologiesStrong PC literacyDesirable Job CompetenciesPositive, “can do”, flexible attitude.Collaboration and teamwork when working with key partnersProblem solver to assist the business in ensuring regulatory complianceTeam playerResults OrientedGood communication and interpersonal skillsWhat will you get from Ansell?· Competitive compensation plan, base salary, and annual incentive· Health Benefits: medical, dental and wellness programs· Collaborative and Innovative work environmentEqual 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 InclusionAnsell’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.