Regulatory and Affairs Specialist

  • Englewood Cliffs, NJ 07632, USA
  • Full-time

Company Description

Our Mission

WOONGJIN, Inc. is a rapidly growing team who provides a range of unique, exceptional, and enhanced services to our clients. We have a strong moral code that includes the service of goodness without expectations of reward. We are motivated by the sense of responsibility and servant leadership.

Job Description

In this role, the RA Specialist will be responsible for the company's regulatory aspects from duties including maintaining data integrity, reviewing records, assisting with preparation internal audits, and ensuring all clinical trials proceed with proper rules and regulations. 

  • Explain regulations, policies, or procedures
  • Maintain data in information systems or databases
  • Ensure compliance with regulations
  • Advise others on regulatory and compliance matters
  • Evaluate applicable laws and regulations to determine impact on company activities
  • Provide technical review of data or reports
  • Tissue Bank & Medical device registration
  • Update on FDA guidance and ISO regulations
  • Responsible for all labeling
  • Responsible for 510k clearance
  • Identify and interpret relevant regulatory guidelines

Qualifications

  • Able to multi-task and work independently
  • Excellent written and verbal communication skills
  • Able to manage time effectively
  • Proficient in MS Office Suite
  • Background in Regulatory Affairs is a plus
  • BA in related field

Additional Information

All your information will be kept confidential according to EEO guidelines.