Job Description The Medical Device Safety team is a highly diverse department that plays a critical role in conceptualizing, designing, and implementing high-priority analytical strategies, clinical oversight, and initiatives. The team is a high-profile, high-impact group that collaborates with PPS functions on various product initiatives. As a team member, you will work with leaders to identify critical priorities and drive high-value projects that impact patient safety. You will assist with ongoing continuous improvement projects across departmental needs. You will be responsible for individual and periodic medical device safety reporting and PI site notifications. You will support training and automation efforts and provide medical safety consultation on risk/benefit and proper product safety usage as needed. Gain understanding of risk management regulations, standards, and guidance for medical devices and combination products. Qualifications Bachelor of Science in Nursing or a related major in Nursing Biomedical engineer or RN required Proficient in Microsoft Office, Data Analysis, Research, Data Automation, and case processing of Device SAE/AEs, device complaints, and SADE potential cases Knowledge of R&D and regulatory guidelines (e.g., ICH, GCP, CFR, EU-MDR, safety reporting) Clinical Trial and Device Experience Knowledge of electronic databases (e.g., Rave EDC, Veeva EDC, Oracle, Salesforce) Strong interpersonal, multitasking, and prioritization skills Results-oriented with strategic decision-making and negotiation skills Ability to facilitate change, manage conflicts, and problem-solve independently and collaboratively Business awareness and effective cross-functional communication skills Focus on execution, results, and process improvement Benefits Healthcare Insurance: Coverage through BlueCross BlueShield of Illinois, eligibility after 60 days of employment, premiums subsidized. Dental Insurance: Coverage through MetLife, eligibility after 60 days. Vision Insurance: Coverage through VSP, eligibility after 60 days. 401(k) Plan: Investment savings plan available to employees 21 or older, with enrollment each January 1st, April 1st, July 1st, and October 1st. Technical Certification Bonus: Up to $500 for approved professional certifications, awarded 90 days after documentation is received. Synectics is an equal opportunity employer. #J-18808-Ljbffr Synectics Inc.
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