KEY RESPONSIBILITIES:
Typically responsible for two or more of the following duties:
- File Medical Device Report (MDRs) for Incident and Mandatory reports with respective regulatory agencies; provide status update and additional information as requested by the agencies.
- Analyze and prepare trend reports for senior level management and take appropriate action to ensure patient safety, regulatory reporting requirements and compile regular reports for management. Communicate with internal departments to determine or resolve issues in order to process recalls and product quality complaints.
- Conduct Adverse Event and Recall Training.
SPECIFIC KNOWLEDGE & SKILLS:
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- Understand FDA, ISO requirements and provide guidance to junior members of the team.
- Knowledge of Microsoft Word, Excel and Access required.
- Knowledge of FDA Medical Device Reporting Requirements, Medical Device Directive (MDD) Reporting requirements, GMP and ISO 9001 & 13485 certification and maintenance.
GENERAL SKILLS & COMPETENCIES:
- Excellent time management skills and the ability to prioritize work
- Attention to detail and accuracy
- Customer service oriented
- Interpersonal communication skills
- Plan and arranges activities
- Very good written and verbal communication skills
- Ability to maintain confidential information
- Ability to work in a team environment
- Ability to multi-task
- Capacity to work under pressure
- Proficient in MS Office
WORK EXPERIENCE:
Typically 3 or more years of related experience.
PREFERRED EDUCATION:
General education, vocational training and/or on-the-job training. Bachelor's degree preferred.
The posted range for this position is $54,298 - $74,659, which is the expected starting base salary range for an employee who is new to the role to fully proficient in the role. Many factors go into determining employee pay within the posted range including prior experience, current skills, location/labor market, internal equity, etc.
Other benefits available include: Medical, Dental and Vision Coverage, 401K Plan with Company Match, PTO, Paid Parental Leave, Income Protection, Work Life Assistance Program, Flexible Spending Accounts, Educational Benefits, Worldwide Scholarship Program and Volunteer Opportunities.
Henry Schein, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
For more information about career opportunities at Henry Schein, please visit our website at: www.henryschein.com/careers