EDUCATION & COMPETENCIES

• Bachelor of Science, a Health science related background is a plus, such as dietitian, pharmacist, nurse etc.
• RAC certification a plus
• 2-3 years Medical Device experience in activities such as aggregate data review, Risk Assessment, DFMEA review, and patient safety
• Data analytics / strong excel, PowerBI and/or data visualization skills
• Medical knowledge to apply critical thinking and data analysis to Medical Safety data and/or Medical Device risk assessments.
• Basic understanding of Global Medical Device regulations (primarily EUMDR, MedDEV), clinical research, and international guidelines/ standards related to medical devices (ISO, GSPR, MDGC etc.)
• Willingness to learn other applicable Medical Device regulations, standards and guidelines
• Drive to adhere to standard operating procedures (SOPs)
• Strong ability /experience in presenting medical and scientific training/ data orally and in writing
• Computer proficient (Windows, Word, Excel)
• Enjoys working in a collaborative environment and with a multidisciplinary, Global team.
• Works independently
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PURPOSE OF THE JOB

As an individual contributor, with guidance from manager/team, functions to support Medical Safety & Surveillance (MSS) by reviewing, assessing, and summarizing medical device complaint information for complex investigations and risk assessments. Critically assess aggregate safety data from medical devices and communicates findings to internal stakeholders. Independently creates and delivers device medical safety training to a Global audience. Drafts documentation, including data reviews, clinical evaluations, literature reviews and standard operating procedures.

MAJOR RESPONSIBILITIES

• Create and present medical safety related analyses, reports, and/or assessments orally and/or in writing within/ outside the Medical Safety and Surveillance department
• Gather, critically analyze, and present findings from Medical Safety and Surveillance complaint data on a periodic basis. Including tracking and trending activities.
• Ensures adherence to departmental standard operating procedures (SOPs), and draft new SOP as needed.
• Comfortable developing Medical Safety and Surveillance training materials and have strong presentation skills to provide training to a broad international audience.
• May write or assist in preparing, completing literature or website searches and data analysis for regulatory documentation supporting medical device registration.
• Conduct periodic literature searches, summarize findings and present information to a cross-functional team.
• Will act as a back up to colleagues on day-to-day medical device complaints processing and conduct medical follow up calls to customers as needed to obtain adverse event and/or complaint details
• As needed, determine complaint reportability to the competent authority; drive on-time vigilance reporting within regulatory time-frames
• Other duties/projects/support as assigned.