Regulatory Affairs Specialist
QUALIFICATIONS:
Minimum education required:
- A Bachelor’s degree is required in a scientific field
- Minimum experience (number of month/years and type of work experience beyond formal education) required for competent performance:
- A minimum of 4 years of related 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 projects simultaneously is required.
- Excellent English written and oral communication skills are required.
- Proficiency in Microsoft Office and all related applications is required.
JOB GOAL:
- Regulatory Specialist – International Registrations is responsible for generating and providing technical documentation to maintain global product registrations for EMEA, LLATAM 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
