Hybrid Manager, Regulatory Affairs

at Life´n Tech

• Job title: Manager, Regulatory Affairs
• Job type: Full Time
• Experience level: Mid level, Senior
• Salary: Not specified
• Degree requirement: Postgraduate Degree
• Location requirements: Hybrid, Sao Paulo, Brazil

About the role

• Manager overseeing regulatory affairs for a German implant company in facial and trauma products. Ensuring compliance with regulations, preparing submissions, and advising on medical affairs.

Responsibilities

• Ensure our products comply with the regulations in the regions where we plan to market them;
• Stay up to date with national and international legislation, guidelines, and customer practices;
• Collect, collate and evaluate scientific data from a variety of sources;
• Develop and write clear justifications and explanations for marketing authorizations for new products and renewals;
• Prepare submissions for variations and license renewals within tight deadlines;
• Monitor and set timelines for license variations and renewal approvals;
• Work with specialized software and computer tools;
• Write clear, accessible product labels and patient information leaflets;
• Plan and develop product tests and interpret test data;
• Advise manufacturers on regulatory requirements;
• Provide regulatory support to teams involved in new product development;
• Conduct and manage regulatory inspections;
• Review company practices and provide advice on changes to systems and processes;
• Maintain contact with and deliver presentations to regulatory authorities;
• Negotiate with regulatory authorities to obtain marketing authorization;

Requirements

• Knowledge of the implant industry and additional training in regulatory affairs;
• Knowledge of medical law;
• Experience preparing registration dossiers for ANVISA;
• Good knowledge of Quality Management — responsibility for required facility licenses;
• Fluent English — daily interaction with the global team;
• Advanced Spanish is a plus;
• University degree and postgraduate qualification (scientific studies completed — pharmacist or related fields);

Benefits

• Meal allowance;
• Performance bonus;
• Health insurance;
• GYMPASS;
• Parking;