We are a Brazilian biotechnology-driven company committed to advancing the understanding of life and building a more sustainable, healthy, and prosperous future. We support scientific progress, environmental awareness, public health, and collective well-being by developing technologies that empower scientists and professionals. Our environment is collaborative, dynamic, and challenging — ideal for fast learners who value idea exchange and wish to grow alongside us. Our culture is guided by continuous growth, resilience, excellence, and the **Loccus DNA**, which values integrity, perseverance, and an entrepreneurial mindset. We expect all team members to demonstrate effective communication, personal accountability, and continuous learning. **Job Mission:** Ensure the company’s and its products’ regulatory compliance with relevant regulatory authorities, managing both corporate licensing and product notification, registration, and listing processes. * Develop, implement, and evaluate risk analyses within regulatory strategies for new products, changes, and/or modifications to existing products; * Review marketing materials, texts, product labeling, and instructions for use of health-related products to ensure compliance with current regulations; * Manage technical files—both physical and electronic—ensuring they remain up-to-date and compliant (for both company and products); * Support management in analyzing data obtained through the area’s KRs to validate achievement of the organization’s strategic plan; * Lead the preparation, review, and submission of regulatory documents: Company (licenses, permits, etc.); * Lead the preparation, review, and management of notification and registration dossiers for Health Products; * Assess the need for modifications to notifications/registrations with regulatory agencies and lead and ensure execution of such processes; * Monitor regulatory processes with regulatory agencies and other government entities; * Monitor, interpret, and stay updated on current regulations and guidelines; Develop letters, declarations, and guidance materials related to regulation and internal procedures; * Interact with internal teams and regulatory authorities to ensure product compliance; * Lead preparation for regulatory inspections and actively participate in audits and inspections; * Provide technical-regulatory support to other company departments; * Conduct training sessions for the team and other corporate members, as well as train and develop Junior and Pleno Analysts when required; * Draft technical responses to requirements issued by regulatory agencies; * Evaluate and propose corrections for potential NCs, recommend corrective and preventive actions, and lead implementation of such actions; * Lead coordination with relevant departments in cases of technovigilance; * Independently manage corporate licenses; * Develop risk mitigation strategies and action plans to ensure ongoing compliance; * Participate in the development and implementation of internal processes related to regulatory compliance; * Support strategic decision-making regarding product launches, discontinuations, risks, and others. * Establish and maintain communication with regulatory agencies. **Mandatory Requirements** * Knowledge of regulations — RDC 665/22, RDC 830/23 * Postgraduate degree in Regulatory Affairs or related fields * Degree in Pharmacy or similar disciplines * Advanced proficiency in Microsoft Office **Desirable Requirements (Differentiators):** * Minimum 5 years of experience in Regulatory Affairs, preferably in medical devices * Advanced English proficiency **Work Model:** * On-site **Working Hours** * Monday to Friday, from 8:00 AM to 5:48 PM\. **Benefits:** * Meal allowance; * Transportation allowance; * Health insurance; * Dental insurance; * WellHub (Gympass); **Why Join Our Team?** Why choose Loccus? You will be part of a cohesive, purpose-driven team. You’ll enjoy autonomy to create, innovate, and learn every day. You’ll work on projects delivering real societal impact and thrive in an environment where growth is continuous and collective. If you seek a place to evolve, connect with a genuine purpose, and put your talent into action, join Loccus. Here, innovation starts with you.
João Silva
Indeed · HR
João Silva
Indeed · HR
