Regulatory Affairs Manager
Há 7 dias
Zimmer Biomet is seeking a highly skilled Regulatory Affairs Manager to join our team in Brazil. As a key member of our regulatory team, you will be responsible for managing all facets of regulatory and quality functions to market Zimmer Biomet products in Brazil.
Key Responsibilities- Develop and manage regulatory submissions, including labeling and product approvals.
- Manage departmental projects, including quality management systems and regulatory compliance.
- Provide guidance and consultation on domestic and international regulations.
- Lead the local quality management system of a distribution site.
- Interact with governmental agencies and manage a staff of regulatory and quality professionals.
- Manage systems for assembly, distribution, storage, tracking, and retrieval of information pertinent to the regulatory process.
- Serve as RAQA leader, interacting and collaborating with local General Manager and cross-functional leaders.
- Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval.
- Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
- Keep all areas of Zimmer Biomet informed of RAQA requirements and emerging issues.
- Supervise local labeling requirements, evaluation of promotion and advertising material for compliance with applicable regulations.
- Establish Zimmer Biomet RAQA policies and procedures and ensure compliance with regional QMS.
- Communicate with Regulatory/Governmental agencies and industry associations.
- Responsibility for oversight and prioritization of departmental tasks and projects.
- Direct and oversee the work of regulatory and quality professionals.
- Bachelor's degree required; concentration in life sciences or related field, preferred.
- Advanced English level is required.
- Solid experience in Regulatory Affairs, including preparation of submissions to Governmental Agencies, quality, and QMS requirements.
- Experience in medical device industry, biologics, and/or combination products is preferred.
Up to 20%
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