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Form of workAre you looking for an exciting opportunity where you can utilize your expertise as a Reporting Specialist? Look no further! We are currently seeking a talented individual to join our Tissue team as a Reporting Specialist II. In this role, you will have the chance to work alongside internal and external stakeholders, ensuring the accurate and timely reporting of complaints. You will collaborate with various teams, including pharmacovigilance and device quality assurance, to guarantee compliance with regulations. As a subject matter expert, you will also have the opportunity to manage more complex reporting needs and provide mentorship to junior team members. If you are seeking a challenging position where you can make a significant impact, this role is perfect for you. Apply now and join our team of dedicated professionals!
Responsibilities- Decision maker for 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 and effectively communicate throughout
- Manages more complex reporting needs and external requests (i.e. from the FDA)
- Manage the timeline for end to end reporting
- Owns translation services for reporting
- Seeks efficiencies and ways to continuously improve our existing processes
- Provide mentorship to Reporting Specialist I team members
- Bachelor's Degree strongly preferred; preferably in the life sciences, pharmacy, nursing, or other scientific background
- 7 years of work experience in a cGMP related industry or in a clinical setting (preferred)
- Knowledge of global regulatory requirements for pharmaceutical, medical devices and combination products.
- In-depth 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.
