Regulatory Affairs Specialist - Hercules, United States - Synergy Solutions

Synergy Solutions
Synergy Solutions
Verified Company
Hercules, United States

15 hours ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description
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:
$ $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
More jobs from Synergy Solutions
See all jobs of Synergy Solutions