QA Specialist I (Complaint Reporting Specialist-Medical Device)

Duration: 6 months contract, Full-Time

Employment Type: W-2

Work Schedule:

• Hybrid schedule 3 days onsite and 2 days remote.

• Start times flexible after training.

Job Description:

Preferred qualification of Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211). The Reporting Specialist I is responsible for executing all of the reporting, in partnership with internal and external stakeholders. The individual will also partner with internal teams such as pharmacovigilance, local in-country teams, and the device quality assurance team to ensure the appropriate and accurate reporting of complaints. They will interface with regulators and serve as the liaison to the respective team when questions and requests arise.

Responsibilities:

• Decision maker for all reportability decisions.

• Lead for all vigilance reporting, including local and global submissions.

• Partners with pharmacovigilance, regulatory affairs, in-country teams, and device QA for submissions and escalates requests as appropriate.

• Ensures that relevant stakeholders have visibility to the reporting and where they are in the process.

• Manages regular reporting needs and external requests (i.e. from the FDA).

• Manage the timeline for end-to-end reporting. • Owns translation services for reporting.

• Focus is dealing with device regulation, not customer facing or intake.

Top skill requirements:

• Derma products and/or medical device regulations.

• Complaint handling experience highly desirable.

• Pharmacovigilance, case file view for AE.

• Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.

• Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211) is preferred.

• Ability to prioritize multiple projects to ensure compliance with regulations and standard operating procedures is preferred.

• Knowledge and application of computer systems for word processing and complaint management, OneTrack system, OneVault.

• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

• Clinical background including bio background, nursing, physicians from other countries without US practice works out well.

• Degree is required.

Years of experience required:

• 1+ year experience with degree.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Recruiter Details:

Name: Shivangi

Email:

Internal Reference Id: 24-10199