The Opportunity
Responsible for timely review, documentation and filing of Medical Device Reports to the FDA (US), Medical Problem Reports to Health Canada, Medical Incident Reports to the EU / EFTA including France, and Medical Device Incident reports to the rest of world for the division's products.
Accountable for meeting the compliance requirements for Medical Device Reporting regulations including (803). This includes but is not limited to : the efficient and timely review, documentation and filing of potentially reportable events.
What You’ll Work On
Review medical complaints and potentially reportable events, gather required additional information to determine the reportability of the complaint in accordance with regulations.
Document filing decision rationale in the Complaint Handling System.
Ensure timely submission of reportable medical events and malfunctions to regulatory authorities in accordance with local and international regulations.
Monitor the status of submitted vigilance reports and ensure follow up actions are completed in timely manner.
Collaborate with internal teams such as customer service, Complaint evaluation group and complaint investigation team to gather necessary information for vigilance reports.
Provide feedback and recommend solutions within the Quality team to promote accurate documentation of the complaint case.
Assist in maintaining the Malfunction Reportability Assessment Matrix (MRAM), including updates to the Reportable Confirmed Malfunction List (RCML).
Perform verification of MDRs / Viglance reports, including support of data complied for metrics, risk evaluations and various other activities.
Stay updated on regulatory requirements, internal Quality System procedures and guidelines related to medical device vigilance reporting.
Adapt processes and documentation to align with updated regulations.
Interface with management and other functional areas to ensure that Potential Reportable Events (PREs) are obtained in a timely and consistent basis.
Required Qualifications
Bachelors Degree in related field or an equivalent combination of education and work experience
Minimum of 1 year of experience in Regulatory and 1 yr of experience with Medical Events reporting
Preferred Qualifications
Ability to communicate at all levels with clarity and precision both written and verbally.
Excellent problem-solving and critical-thinking skills.
Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
Multitasks, prioritizes and meets deadlines in timely manner.
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