Senior regulatory affairs specialist, brazil about the role the purpose of the senior regulatory affairs specialist role in brazil is to provide regulatory support and guidance that will enable timely device registrations and helping ensure that cochlear is compliant with premarket and post market regulatory requirements for all cochlear products sold in brazil, including applicable local certifications. This role closely collaborates with global, regional and local roles to ensure regulatory compliance in brazil by providing product support and maintenance. Key accountabilities will include: accountability 1: support regulatory strategy and planning participate in the development and implementation of the regulatory registration plan in brazil, including local certifications, in close cooperation with regional and local functions (such as sales, marketing and clinical) in order to achieve timely regulatory approval and registration of product. Coordinate the maintenance of the registrations and local certifications (electrical, radio frequency) in line with prioritization and renewal plan, in a timely manner. Accountability 2: regulatory submissions and related activities adapt or create technical dossiers appropriate for the local market submissions: independently write executive summaries and compile documents for submissions of all types in line with registration plan. Ensure company business plans are met by organizing the request, approval and maintenance of local certifications (anatel and inmetro) in line with registration and launch plans. Follow up on regulatory applications within agreed timelines, coordinating support for the local distributor in working with regulatory authorities. Provide final documented assessment of any impacts of changes to devices, labeling, or manufacturing processes with an appropriate level of justification. Serve as subject matter expert for global colleagues. Manage timely regulatory submissions and approvals for changes in certificates. Follow up all submission and renewal activities in a timely manner. Accountability 3: provide cross-Functional regulatory direction establish and maintain fluid communication with the local distributor to ensure an accurate understanding of the regulatory activities. Plan and execute regulatory audits. Inform global ra teams about new or changing national regulations/trends in responsible markets. Maintain fluid communication with regional cla teams to support regional objectives. Support the development and implementation of better regulatory practices and processes. Team role (individual contributor): follow relevant quality procedures in order to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.G. Audit) when appropriately trained to undertake these responsibilities. Contribute ideas on systems and process methods to improve deliverables. Work safely, complying with all safety procedures, rules and instructions and reporting workplace hazards, incidents or injuries to manager. Key requirements: minimum: bachelors degree in legal, scientific or healthcare and 5+ years experience in regulatory affairs and or quality in pharma or medical devices companies. Good communication, analytical and planning skills ability to influence others ability to manage stakeholders at all levels within the business and work collaboratively in cross-Functional teams. Ability to communicate and build relationships with regulators, as needed. Ability to apply knowledge of global regulatory requirements for medical device. Fluency in english and portuguese languages required ideal: 7+ years experience in regulatory affairs for medical devices including compilation, submission and maintenance of regulatory filings. Working knowledge or fluency in spanish region-Specific requirements: knowledge and interpretation of brazilian regulations.
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