Job Description:
Purpose:

• 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 report ability 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

Qualifications:

• 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.
• Solid written/verbal communication and organizational skills.
• Knowledge and application of computer systems for word processing and complaint management.
• Ability to work with cross-functional teams and to interact effectively with peers, management, and customers.

Job Types: Full-time, Contract

Pay: Up to $29.56 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance

Schedule:

• 8 hour shift

Experience:

• Quality assurance: 3 years (Preferred)
• FDA: 2 years (Preferred)

Ability to Relocate:

• North Chicago, IL: Relocate before starting work (Required)

Work Location: In person