1. Share clinical knowledge with researchers and projects stakeholders and collaborate with external partners/customers in the planning and execution of innovative commercial and clinical research projects.
2. Contribute to the health data analysis and decision-making process in collaboration with internal teams.
3. Conduct designing of clinical trial protocols comprising medical and non-medical wearable devices for health, wellness and fitness purposes.
4. Support Regulatory related activities: Submission and follow-up of research projects to regulatory entities and risk assessment of current and new projects from regulatory and data management standpoints.
Role and Responsibilities
Coordinate all activities relating to regulatory compliance and the submission of specified documentation;
Prepares and submits regulatory report/process for FDA and ANVISA;
Working knowledge of current devices regulation;
Ensures compliance with regulatory agency regulations and interpretations;
Prepares responses to regulatory agencies questions and other correspondence;
Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines;
Involved with the preparation of necessary for necessary outlines, summaries, status reports, graphs and slides;
Provides solution to a variety of problems of moderate scope and complexity;
Provide regulatory affair support during internal and external audits;
Knowledge of Federal Regulations;
Demonstrated written and verbal communication skill;
Strong time management skills, with the ability to work on multiple projects simultaneously;
Ability to work independently as well as within a team;
Excellent medical devices written and verbal communication skills in English and Portuguese;
Ability to organize and prioritize workflow;
Achieved regulatory approvals for Medical devices;
Enthusiastic of Artificial Intelligence for health.
Skills and Qualifications
PhD and/or MSc: Regulatory Affair, Medical Sciences, Biomedical Sciences, Biology, Pharmacy, Engineer, or the equivalent combination of the education and experience obtained from a university with solid professional experience.
Experience in FDA/CEP/CONEP regulated, Medical Device and/or Scientific Experience.
Written and verbal fluency in Portuguese and English.
Confidential and proprietary information obtained by you during your employment history in other companies must be maintained as such (confidential & proprietary) throughout the selection process, not in any event, be opened or shared with the interviewers.
|Posted on:||19 Mar 2023|