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Masimo

Regulatory Affairs Specialist I

Posted 10 Hours Ago
Be an Early Applicant
In-Office
Irvine, CA
20-28 Hourly
Junior
In-Office
Irvine, CA
20-28 Hourly
Junior
Manage international regulatory filings, coordinate product changes, ensure compliance with RoHS/WEEE, and maintain product documentation and certifications.
The summary above was generated by AI

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. 

Top Skills

Access
Excel
Ms Office (Word
Outlook)
HQ

Masimo Irvine, California, USA Office

52 Discovery, Irvine, California, United States, 92618 3108

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