Medical Product Reporting Specialist

1 month ago

North Chicago, United States Collins Consulting Inc Full time
This is a hybrid position, 3 days onsite and 2 days remote. (Start times are flexible after training)

Job Description:
If candidate has preferred qualification of Knowledge of FDA Quality Systems, pharmaceutical products, and Medical Device Reporting regulations (21 CFR 803, 820 and 211), that is a plus.

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 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

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.

Years of experience/education and/or certifications required:
  • 1+ year experience

What are the top 3-5 skills requirements should this person have?
  • 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.

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?
  • Degree is preferred
  • Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
  • Clinical background including bio background, nursing, physicians from other countries without US practice has worked out as well.

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