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
Pay: $30.00 - $38.00 per hour
Expected hours: 40 per week
Shift:
- Day shift
Weekly day range:
- Monday to Friday
Work setting:
- Hybrid work
Application Question(s):
- How many years medical device quality complaints experience do you have?
- Are you proficient ISO 13485?
- Can you commute to Irvine Mondays and Thursdays?
Education:
- Bachelor's (Preferred)
Ability to Relocate:
- Laguna Niguel, CA 92677: Relocate before starting work (Required)
Work Location: Hybrid remote in Laguna Niguel, CA 92677