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
  

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

Supervision/Authority

• No supervision to others

Job Goal:

• Regulatory Specialist – International Registrations 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 (including the management of obtaining non-technical documents such as Certificates to Foreign Government, legalized/apostilled documents, etc.) to regulatory teams in Latin America, Asia Pacific, Japan and Europe, Middle East and Africa for product registrations.
  

• Work with regulatory partners to ensure execution and approval of product registrations in accordance with project plans. 
  

• 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

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