Regulatory Affairs Specialist I
BD
full-time
Posted on:
Location Type: Hybrid
Location: Covington • 🇺🇸 United States
Visit company websiteJob Level
Junior
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory support510(k) preparationIDE preparationPMA preparationinternational submissionsproduct labeling reviewmarketing claims approvalCE marking activities
Soft skills
excellent written communicationexcellent verbal communication
Certifications
Regulatory Affairs Certification (RAC)