Job Overview – Medical Device Complaint Specialist
Compensation: $35/hour
Location: Remote
Schedule: Monday to Friday
Atlantic Group is hiring a Medical Device Complaint Specialist (Remote) for our client, supporting complaint handling, regulatory assessment, and quality documentation in a medical device environment. This role focuses on complaint review, reportability assessment, and investigation support while analyzing complaint data and trends. The position requires strong attention to detail, data analysis skills, and experience with quality systems and complaint handling processes.
Responsibilities as the Medical Device Complaint Specialist:
- Complaint Review: Evaluate complaints for completeness, accuracy, and regulatory reporting requirements.
- Data Analysis: Analyze complaint and product data to identify trends, patterns, and potential quality issues.
- Documentation: Maintain accurate records and review documentation including device history records and complaint files.
- Reporting: Support preparation of reports, trending analysis, and regulatory documentation.
- Audit Support: Assist with internal and external audits including FDA and quality system reviews.
- Training and Support: Provide guidance to team members on complaint processes and support cross-functional communication.
Qualifications for the Medical Device Complaint Specialist:
- Education: Bachelor’s degree is required or equivalent experience in a related field.
- Experience: 1-2 years of experience in medical device complaint handling, quality, or data management is required.
- Industry Knowledge: Understanding of medical device regulations and complaint handling processes is preferred.
- Technical Skills: Proficiency in Excel and database systems is required.
- Skills & Attributes: Strong attention to detail, organization, communication skills, and the ability to manage multiple priorities in a fast-paced environment are required.
Application Notice: Qualified candidates will be contacted within 2 business days of application. If an applicant does not meet the above criteria, Atlantic Group will keep your resume on file for future opportunities and may contact you for further discussion.