Global Regulatory Affairs Associate

Growing Westchester, NY Manufacturer is seeking a Global Regulatory Affairs person to become the newest member of its 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 & 1m Medical Devices including USA, Europe, Japan, Asian Pacific, and Switzerland.

Primary Responsibilities:

·        Gather and analyze the necessary data to ensure compliance with domestic and international regulatory requirements for Class I Medical Devices

·        Ability to interpret rules set by governmental and certifying organizations

·        Provide regulatory support to the International Department-filling out questionnaires, Regulatory documents, forms etc.

·        Develop documents and reports for the appropriate federal and global regulatory agencies

·        Provide support in updating the company’s Quality System and Quality Manual to ensure it conforms with all Domestic and International standards for relevant markets

·        Assist 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 communication skills

Experience in the medical device industry is a plus

Job Type: Full-time – In Office

Salary Range: $80,000 - $90,000