Regulatory Affairs Specialist
Há 1 mês
Zimmer Biomet is a global medical technology leader seeking a highly skilled Regulatory Affairs Associate to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements for our medical devices in Brazil.
Key Responsibilities
• Evaluate the risk of proposed regulatory strategies and provide solutions
• Assess proposals for changes to product registrations and communicate the regulatory impact in Brazil
• Develop and maintain control of product registration processes, renewals, post-registration changes, compliance with regulatory requirements, and requests for Good Manufacturing Practices
• Contact product responsible personnel in other countries to request documentation necessary for the above-mentioned processes according to current sanitary legislation
• Analyze and inform the impact of publications in the Official Gazette, both for product registrations and new applicable legislation
• Participate in Public Consultations for new applicable legislation, association meetings, and sector meetings
• Follow up on INMETRO and ANATEL certification processes, from contact with recognized certification bodies to scheduling and conducting international factory inspections for compulsory certification
• Ensure the regularization of the company with sanitary authorities
• Provide regulatory support for the importation of products
• Communicate with regulatory agencies
• Maintain systems, databases, and indicators up-to-date
• Support marketing in the development, correction, and approval of promotional materials
Requirements
• Bachelor's degree
• Minimum 2 years of experience in Regulatory Affairs
• Experience in regulatory submission/consciousness in legislation for health products
Travel Expectations
Up to 10%
Zimmer Biomet is an equal opportunity employer.
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