Regulatory affairs manager – São Paulo/SP

SP | São Paulo
Efetivo (CLT)
Biólogo
Biomédico
Bioquímico
Farmacêutico

What Makes You Stand Out

• Demonstrated strong writing and communication skills; ability to communicate effectively at multiple levels, including with regulatory agencies, superiors, peers, and direct reports
• Strong interpersonal, organizational, problem-solving and analytical skills; strong attention to detail;
• Ability to manage competing priorities; versatility, flexibility, and willingness to work with changing priorities;
• Advanced knowledge of overall business environment, the orthopedic industry and the marketplace;
• Mastery of relevant regulations, and ability to stay abreast of regulations pertinent to medical devices, biologics and combination products as applicable;
• Ability to function well as a member of the team and team leader, as well as build relationships between RAQA and other areas of the organization;
• Ability to identify and asses business risks to develop Regulatory strategy;
• Ability to build and lead a strong RA team; ability to lead and influence others;
• Strong systems and Microsoft Office knowledge;
• Advanced knowledge of specific country health regulations(including labeling regulations) and regulations outside of the US/EU as applicable;
• Quality Assurance knowledge is preferred.

Your Background

• Bachelor´s degree required; concentration in life sciences or related field, preferred;
• Advanced English level is required;
• Solid experience in Regulatory Affairs, including preparation of submissions to Govermental Agencies, quality, and QMS requirements;
• Experience in medical device industry, biologics, and/or combination products is preferred.