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 Type: Contract
Job Type: Full-time
Pay: $30.00 - $40.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Experience level:
- 2 years
Schedule:
- Monday to Friday
Work setting:
- Hybrid work
- Office
Application Question(s):
- Are you proficient ISO 13485?
- Are you ok working onsite Monday and Thursday in Irvine ca?
Education:
- Bachelor's (Preferred)
Experience:
- COMPLAINTS SPECIALIST: 1 year (Preferred)
Ability to Relocate:
- Santa Ana, CA 92707: Relocate before starting work (Required)
Work Location: Hybrid remote in Santa Ana, CA 92707