What are the responsibilities and job description for the Global Regulatory Affairs Associate position at Fabrication Enterprises Inc?
FEI is seeking a Global Regulatory Affairs associate to become the newest member of its growing Regulatory/Quality team. The Global Regulatory Affairs Associates will provide support to internal staff and external customers to ensure that all global regulatory requirements and compliance needs are fulfilled according to legal and corporate guidelines. The ideal candidate is a detailed oriented and highly organized individual who has knowledge of the Regulatory Requirements/Standards for global markets for Class I Medical Devices including USA, Europe, Japan, Asian Pacific, and Switzerland.
Primary Responsibilities:
- Gathers and analyzes information to ensure compliance with domestic and international regulatory requirements for Class I Medical Devices.
- Interprets rules set by governmental and certifying organizations.
- Provides regulatory support to the International Department-filling out questionnaires, and regulatory documents.
- Develop documents and reports for the appropriate federal and global regulatory agencies.
- Responsible for managing UDI medical device data listings in the required database, enabling compliance with UDI regulations in all appropriate global markets.
- Provides support in updating the company Quality System and Quality Manual to ensure it conforms with all domestic and international standards for relevant markets.
- Assists with regulatory audits.
- Other duties as assigned by management.
Educational Requirements
- Bachelor’s degree or equivalent relevant work experience (BA/BS preferred)
- International regulatory experience
- Excellent writing and verbal communications skills
- Experience in the medical device industry
