Regulatory Affairs Associate

Location

Port Washington, NY

Description

GENERAL STATEMENT OF DUTIES:

Provide hands-on support with respect to overall corporate/supplier compliance to governmental regulatory requirements for medical devices in the United States, Canada the EU and abroad.

 ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Work with Manufacturers, Distributors and third party agent to register Drive’s products around the globe
  • Assist sales team in regulatory filings for foreign registrations relating to Drive Medical business
  • Support Canadian subsidiary with compliance issues for new and existing product
  • Partner with Compliance and Risk Management to assess customer complaints and product claims for adverse events and reporting requirements under 21 CFR Part 803
  • Support activities associated with product corrections and removals as specified under 21 CFR Part 806
  • Participate with New Product Concept team  in assessing regulatory requirements of new products in multiple markets
  • Provide support as required to senior levels in Regulatory Affairs and Compliance
  • Keep abreast of changing regulation related to Drive’s Global position
  • Other duties may be assigned

Requirements

QUALIFICATIONS, KNOWLEDGE, AND SKILLS:

  • Positive outlook
  • Solid analytical skills
  • Attention to detail
  • Basic understanding of FDA QSR regulations under 21 CFR Part 800 with a focus on Part 803 & 806 is desired
  • Excellent skills in written and verbal communication, and ability to interact with all levels of the organization and suppliers (domestic and foreign)
  • Proficiency in use of computer and office equipment

 EDUCATION AND EXPERIENCE:

  • Bachelor’s degree in Regulatory Science, Life Sciences, Engineering or other relevant field
  • 0 - 2 years of industry experience
  • Experience working in a FDA regulated environment is a plus

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