Registration Lead
Qualifications:
Minimum education required:
A Bachelor’s degree is required in a scientific field
Minimum experience:

• A minimum of 4 years of Regulatory experience is required
  

• Experience with medical device registration is required
  

• Excellent technical writing skills required
  

• Analytical thinking, problem solving, and investigative skills are required
  

• Experience in the application of Quality Management System Standard ISO 13485, MDD/MDR, and US FDA regulations
  

• Demonstrable track record of successfully managing multiple project simultaneously is required
  

• Excellent English written and oral communication skills are required.
  

• Proficiency in Microsoft Office and all related applications is required.

Supervision/Authority

• No supervision to others

Job Goal:
The Registration Lead is responsible for generating and providing technical documentation to maintain global product registrations for EMEA, LATAM and ASPAC for a large-scale new product and lifecycle management project. 

Responsibilities:

• Coordinate, compile, author, format and supply the required documentation to regulatory teams in Latin America, Asia Pacific, Japan and Europe, Middle East and Africa for product registrations. Work with regulatory partners to ensure on time execution and approval of product registrations outside of the United States
  

• Researches, collects data, and addresses requests from local regulatory teams or regulatory agencies to prepare documentation required for health authority submissions
  

• Work under minimal supervision, with benefit of previous regulatory experience.
  

• Requires a general use and application of Regulatory concepts, practices and techniques.
  

• Develop solutions to a variety of problems of moderate scope and complexity.
  

• Perform other duties as assigned by the manager of this position. Ensure compliance with applicable international regulations and standards
  

• Ensure preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
  

• Assist with responses to health authority questions and other Regulatory correspondence.
  

• Gather and assemble information necessary for submissions in accordance with regulations and relevant guidelines.
  

• Provide regulatory guidance to project teams, as applicable.
  

• Provide support to inspections/audits by government agencies and the notified body by producing requested documents or answering any inquiries for information.

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