Hybrid Regulatory Affairs Specialist I

Posted 3 weeks ago

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About the role

  • Provide regulatory support through the product life cycle
  • Prepare and audit 510(k)s, IDEs, PMA and/or international submissions
  • Collaborate with FDA and international reviewers
  • Review and approve product labeling and marketing claims
  • Support required for CE marking activities

Requirements

  • BS in a scientific field
  • 1+ years employment in medical device product registration, compliance or quality systems
  • Regulatory Affairs Certification (RAC) desired
  • Knowledge of U.S. and European medical device regulations preferred
  • Excellent written and verbal communication skills

Benefits

  • Health insurance
  • Flexible work arrangements
  • Professional development opportunities

Job title

Regulatory Affairs Specialist I

Job type

Experience level

Junior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

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