Product Complaints Specialist

DEKA Research & Development • Manchester, NH

2d

About The Position

DEKA Research & Development, on behalf of Millyard Advanced Technologies, is seeking a detail-oriented Complaint Handling Specialist to support our product quality and regulatory compliance efforts. In this role, you will manage complaint documentation and data entry, ensure records meet FDA and QMS requirements, and collaborate with internal teams and external partners to maintain audit-ready documentation in a fast-paced, regulated environment.

Requirements

• 1+ year of experience in a regulated environment (cGMP, healthcare, clinical, or similar) or in a high-volume data entry/administrative role.
• Strong attention to detail and accuracy in documentation and data entry.
• Effective time management skills with the ability to prioritize tasks and meet deadlines.
• Strong organizational and record-keeping skills.
• Proficient computer skills (Microsoft Office, databases, or similar systems).
• Clear written and verbal communication skills.
• Sound technical writing skills.
• Ability to work independently on routine tasks and collaborate with cross-functional teams when needed.
• Problem-solving mindset with the ability to follow established procedures and escalate issues appropriately.

Nice To Haves

• Basic knowledge of FDA Quality Systems and Medical Device Reporting regulations (21 CFR 803, 820, 211) preferred.
• Experience with data entry systems or CRMs (e.g., Salesforce) preferred.

Responsibilities

• Review, document, and enter product complaint information into internal systems with a high degree of accuracy.
• Request and track additional information needed to complete complaint records and evaluations.
• Perform complaint data entry and preliminary evaluations while collaborating with team members as needed.
• Ensure all complaint records follow Good Documentation Practices (GDP), Quality Management System (QMS) requirements, and applicable FDA/regulatory guidelines.
• Communicate with third-party manufacturers, healthcare professionals, and internal teams to collect and verify complaint details.
• Maintain organized, complete, and audit-ready documentation within complaint handling systems.
• Support updates to procedures and work instructions by providing feedback based on day-to-day processes.
• Maintain professional, clear, and cooperative communication with internal and external contacts.
• Perform other administrative and support duties as assigned under management supervision.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed