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