Gerente de Assuntos Regulatórios - São José do Rio Preto - SP

The regulatory affairs manager is responsible for obtaining and maintaining the regulatory approvals that authorize the company to sell, advertise, distribute, conduct clinical investigations and, in a general sense, legally use its devices in the territories of interest, always in compliance with applicable regulations and taking into account the company's clinical and regulatory operations.

- Leading, prioritizing, planning and reviewing product registrations and clinical investigation approvals in Latin America.

- Coordinate and submit regulatory submissions, both clinical and pre-clinical, to the competent authorities in the region.

- Maintain active knowledge of the status of pending registrations, approvals and submissions and drive these processes through the respective regulatory projects in Latin America.

- Provide national and international leadership with regular updates on regulatory projects in Latin America.

- Manage, inform and educate the clinical and regulatory affairs team in Brazil, the CROs and the RA Country Representatives (Latin America) to maintain good team performance and ensure timely deliveries.

- Monitor, communicate and help the company prepare for regulatory and standardization updates that may affect the company or the development/manufacturing of its devices.

- Establish and implement plans to maintain a relationship of trust with the competent authorities through regular meetings, discussions, training and workshops.

- Establish and implement plans to maintain a relationship of trust with relevant regional medical societies and medical specialists through regular meetings, discussions, training and workshops.

- Establish relationships with local medical device industry associations and work with industry colleagues to influence the relevant authorities on regulatory issues and local policy-making.

- Establish and maintain a good working relationship with head office colleagues (RA, R&D, Clinical, QA etc.) to obtain positive and timely support for document preparation.

- Acting as a regulatory consultant for various internal teams in terms of regulatory strategy and operations.

- Acting as the focal point in Latin America and the person responsible for the progress of the company's clinical development process, including the clinical investigations required to support it.

- Acting as an expert and regulatory focal point on various internal committees, especially for decision-making, the creation and maintenance of processes and the planning of strategic initiatives.

- May, as required, apply training and provide continuing education internally.

- Responsible for training and maintaining all activities necessary for the proper functioning of the regulatory affairs and clinical development processes at a regional level.