Spec 1, Complaint Mgmt
2035 West 4th Street Tempe, AZ 85281 US
Job Description
A-Line Staffing is now hiring a Regulatory Complaint Specialist – Medical Device in San Diego, CA.
The Regulatory Complaint Specialist would be working for a Fortune 500 medical device company and has career growth potential. This would be full time / 40+ hours per week.
If you are interested in this Regulatory Complaint Specialist – Medical Device position, please contact Lindsay at LKopasz@alinestaffing.com or 586-710-7959 .
Regulatory Complaint Specialist – Medical Device Compensation
• The pay for this position is $23.61 – $25.00 per hour
• Benefits are available to full-time employees after 90 days of employment
• A 401(k) with a company match is available for full-time employees with 1 year of service on our eligibility dates
Regulatory Complaint Specialist – Medical Device Highlights
• This position is a 6+ month contract assignment with potential to hire based on attendance, performance, and business needs
• The required availability is 1st shift, Monday–Friday, 8:00 AM – 5:00 PM
• Local candidates only – role will start onsite for training, with remote flexibility once trained
• Interviews will be conducted via phone and video
• Attendance is mandatory for the first 90 days
• Work location: San Diego, CA 92130
Regulatory Complaint Specialist – Medical Device Responsibilities
• Manage customer complaint records from intake through closure
• Accurately document complaint information in TrackWise (or similar electronic database)
• Ensure timely closure of complaints, meeting internal and external regulatory standards (MDR, Vigilance)
• Draft and send acknowledgment and closure letters to customers
• Interact professionally with healthcare providers, patients, and internal teams
• Complete sampling of closed complaint records for accuracy
• Assist with regulatory reporting (e.g., MDR, Vigilance)
• Maintain accurate and compliant records per FDA/ISO guidelines
• Comply with internal Quality System policies and procedures
Regulatory Complaint Specialist – Medical Device Requirements
• Bachelor’s degree in Healthcare, Engineering, or Technical discipline
• Minimum 1–2 years of experience in a customer-facing or service-related role
• Strong attention to detail and problem-solving skills
• Proficient in Microsoft Office (Excel, Word, Outlook)
• Excellent verbal and written communication skills
• High School Diploma or GED
• Attendance is mandatory for the first 90 days
Regulatory Complaint Specialist – Medical Device Preferred Qualifications
• Working knowledge of MDR, Vigilance, FDA QSR, and ISO standards
• Experience using complaint handling software (e.g., TrackWise)
• Previous experience in a medical device or regulated healthcare industry
If you think this Regulatory Complaint Specialist – Medical Device position is a good fit for you, please reach out to me – feel free to call, e-mail, or apply to this posting!