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Job Description:
Collect, review, assess and process complaints/reports with medical device adverse event and device deficiency information clinical studies in a compliant and timely manner to comply with global regulations, which includes but not limited to seriousness assessment, labeling, causality, follow- up data received
Perform medical assessments as needed for post-market device portfolio cases escalating as need to the MDS physician
Maintain understanding of medical device/combination product risk management regulations, as well as applicable standards, and guidance documents
Supports and participates in audits and inspections as needed
Workload responsibilities are primarily medical device safety management related and include some safety higher level functioning (e.g. prioritizing workload, training, reconciliation of databases, safety surveillance).
Troubleshoots problems.
Problem solving involves identification of problems and proper escalation to manager
Mentor/teach others with directions from leadership team by coaching and mentoring designated Medical Device Safety staff on assigned medical device safety activities
Other duties may be assigned based on the need or work requirement of the department deliverables
Qualifications:
Minimum: Bachelor's degree with related health sciences background BSN, BS, or Engineering
Candidates lacking the appropriate degree but with previous medical device experience may be considered
4-7 years medical device safety experience minimum
Must have current RN licensing
Demonstrated ability to lead project work, facilitate cross-collaborative relationships and facilitate meetings with proven success in results-driven process management
PC proficiency (Windows, Word, Excel) and in EDMS (e.g., oracle/clinical, OneTrack)
Critically evaluate medical data and escalate necessary information to Medical Device Safety Physicians as applicable
Accurately and medically present data, both orally and in writing, with the ability to assign tasks to others in Medical Device Safety Physician's absence.
Benefits:
Healthcare Insurance: Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.
Dental Insurance: Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
Vision Insurance: Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.
401(k) Plan: The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first of the month following at least 1 calendar year after employment begins.
Synectics is an equal opportunity employer.
Synectics is a leading staffing and workforce solutions company dedicated to connecting exceptional talent with top organizations. We specialize in IT, engineering, finance, healthcare, and professional services recruitment, offering both contract and permanent staffing solutions. With a people-first approach, we focus on understanding the unique needs of our clients and candidates to create long-term, successful matches. Our mission is to empower businesses with the right talent while helping professionals achieve rewarding career opportunities