Regulatory Affairs Specialist I

Duties and Responsibilities

• Support international filings/registrations
• Coordinate with international regulatory team members on product changes
• Maintain product list on Certificate of Foreign Government
  • Coordinate with Customer Support/Shipping product name consistency
• Maintain up-to-date knowledge on international regulatory requirements
• Maintain RoHS/WEEE compliance for all products
  • Track component certifications and supplier surveys
• Generate Declaration of Conformity
• BA/BS Degree or equivalent
• Minimum 2-5 years of work experience in a related field
• Proficient in MS Office (Word/Excel/Access/Outlook)
• Good verbal and written communication skills
• Good prioritizing, organizational, and interpersonal skills
• Ability to work in a fast-paced environment with multiple tasks/projects

Required Education/Skills

• BA/BS Degree or equivalent
• Minimum 2-5 years of work experience in a related field
• Proficient in MS Office (Word/Excel/Access/Outlook)
• Good verbal and written communication skills
• Good prioritizing, organizational, and interpersonal skills
• Ability to work in a fast-paced environment with multiple tasks/projects

Preferred Education/Skills

• Experience with working in business environments such as legal firms and/or medical device companies
• Experience with FDA/GMP requirements for medical device
• Experience with UL/ETL certification process 
• A detail-oriented individual with a “can do” attitude

Compensation

The anticipated hourly rate for this position is $20hr-$28hr plus benefits.Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience.