Address
Form of work
Salary```Job Summary:```
Essential Onsite- no hybrid. M-F 8:00 to 4:30 however we are flexible. Experience in IVD medical device industry is required
- Provide regulatory support for IVD products with multiple product groups within clinical diagnostics.
- Work with regulatory database to post Instructions for use.
- Assembles low complexity regulatory submissions to support worldwide product registration.
- Basic analytical, communication, problem solving, critical thinking, and database management to meet daily job responsibilities.
- Interface daily with desktop publisher, technical writers and Regulatory Affairs Specialists. Work collaboratively with Marketing, R&D, QA, Planning, and Manufacturing teams.
How You'll Make An Impact:
- Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines
- Ability to communicate effectively with employees across multiple departments
- Highly organized and detail-oriented. Good time management.
- Technical aptitude for understanding IVD product features
What You Bring:
- Education:BS in Biology with emphasis in biology.
- Work Experience: 1-3 years experience in IVD Regulatory Affairs.
- Proficient use of MS Office applications (e.g., Excel, Word, PowerPoint, Teams)
- Laboratory research experience in an IVD medical device regulated environment.
Job Type: Contract
Pay: $35.00 - $40.00 per hour
Schedule:
- 8 hour shift
- Monday to Friday
- Overtime
Ability to Commute:
- Hercules, CA 94547 (Required)
Work Location: In person
