Complaint Specialist - Irvine, United States - T.E.G.

Description

Prestigious billion dollar medical device company targeting a Complaint Specialist to join our fun loving team

Role is temp 3-6 months with possibility to be hired on full time
Hybrid schedule, Monday and Thursday onsite Irvine. Start time flex 7am-9am

Comp $30-$40/hr


Must have:

• Medical Device Class III, or Dental experience
• Complaint Specialist experience process medical complaints specific to medical device
• Explain in detail ISO 13485

DUTIES:

• Evaluates event(s) to determine if it qualifies as a complaint.
• Assesses complaint information provided, gather any missing information for complainant file, and escalates complaint to appropriate parties as needed.
• Manages customer relationship and expectations during course of complaint investigation and resolution process.
• Reviews potential reportable events to determine if regulatory filings are required.
• Ensures compliance with all federal and international regulations applicable to manufactured medical devices.
• Maintains and completes complaint files for all customer complaints according to procedures.
• Maintains awareness of new products and government regulations and requirements.
• Documents and completes complaints in timely manner.
• Prepares and submits final customer correspondence as required.
• Performs other related duties and projects as business needs require at direction of management.

Minimum Qualifications:


Education and Experience:

• Bachelor's degree in science, engineering, or equivalent relevant experience preferred.
• Minimum two (2) years of experience within regulatory affairs or medical device reporting.
• Medical device experience preferred.
• Understanding and interpretation of domestic and international complaint handling and reporting requirements required.

Job Types:
Full-time, Contract


Pay:
$ $40.00 per hour


Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 1 year
• 2 years
• 3 years
• 4 years
• 5 years

Shift:

• Day shift

Weekly day range:

• Monday to Friday

Work setting:

• Hybrid work
• Office

Application Question(s):

• Are you comfortable with a contract/contract to hire role?

Education:

• Bachelor's (preferred)

Experience:

- medical complaints: 1 year (preferred)


Ability to Relocate:

• Irvine, CA 92614: Relocate before starting work (required)

Work Location:
Hybrid remote in Irvine, CA 92614