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Regulatory Affairs Specialist

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Regulatory Affairs Associate

At Zimmer Biomet, we are committed to pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader, we strive to enhance patient mobility and renewed life worldwide.

Key Responsibilities
  • Evaluate the risk of proposed regulatory strategies and provide solutions
  • Assess product registration proposals and communicate the regulatory impact in Brazil
  • Develop and maintain product registration processes, renewals, post-registration changes, compliance with regulatory requirements, and good manufacturing practices
  • Coordinate with product responsible personnel in other countries to request necessary documentation according to current sanitary legislation
  • Analyze and inform the impact of official publications on product registration and new applicable legislation
  • Participate in public consultations of new applicable legislation, association meetings, and sector-regulated meetings
  • Monitor certification processes with INMETRO and ANATEL, from contact with recognized certifying organisms to inspection scheduling and international factory inspections
  • Maintain the company's regularization with sanitary authorities
  • Provide regulatory support for product importation
  • Communicate with regulatory agencies
  • Maintain systems, databases, and indicators up-to-date
  • Support marketing in the development, correction, and approval of promotional materials
Requirements
  • Strong writing and communication skills
  • Strong interpersonal and attention-to-detail skills
  • Ability to effectively communicate at various levels, including with regulatory agencies
  • Ability to manage multiple concurrent priorities; versatility, flexibility, and willingness to work with changing priorities
  • Knowledge of relevant medical device regulations and ability to stay updated on new legislation
  • Ability to identify risk in regulatory strategies
  • Ability to work in a team, be proactive, and create a positive work environment
  • Analytical and negotiation skills, as well as problem-solving ability
Professional Background
  • Bachelor's degree
  • Minimum 2 years of experience in Regulatory Affairs
  • Experience in regulatory submission / knowledge of health product legislation
Travel Expectations

Up to 10%