Regulatory Affairs Specialist

Essential Onsite
- no hybrid. M-F 8:00 to 4:30 however we are flexible.

*Less than 1 year experience in IVD medical device industry is acceptable*
- 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.

**QUALIFICATIONS**:

- Education: BS/BA in life science field required. Emphasis in biology preferred
- Technical aptitude for understanding IVD product features
- Work Experience: 0-2 years experience in IVD regulatory affairs.
- Laboratory research experience in an IVD medical device regulated environment
- Strong prioritization skills, flexibility and ability to handle multiple projects simultaneously while meeting deadlines

**Job Disclaimer**:

- Equal Opportunity Employer/Veterans/Disabled_
- The Company will consider qualified applicants with arrest and conviction records._

**Job Type**: Contract

Pay: $38.00 - $42.00 per hour

Expected hours: 40 per week

**Benefits**:

- 401(k)
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Experience level:

- 1 year

Schedule:

- 8 hour shift
- Day shift
- Monday to Friday

**Education**:

- Bachelor's (required)

**Experience**:

- In vitro diagnostics: 1 year (required)
- Regulatory Affairs: 1 year (required)
- Medical device: 1 year (preferred)

Ability to Relocate:

- Hercules, CA 94547: Relocate before starting work (required)

Work Location: In person