Safety Regulatory Compliance Specialist
Position Summary
The temporary position is responsible for managing device complaints and adverse events globally. This may include : complaint initial triage, submitting regulatory reports in accordance with applicable regulations, referring potential safety cases to applicable department, providing updates to reports, reviewing for closure / reopening as needed, and assuring timely processing of complaints.
Essential Duties & Responsibilities
Responsible for evaluating complaints from patient safety perspective and completing regulatory reporting decisions per reporting requirements globally.
Responsible for creating and submitting regulatory reports to the FDA.
Works independently and is accountable for completing task as assigned.
Works well in a team to accomplish team goals.
Knowledge & Skills
Experience with or knowledge of medical terminology and how medical / pharmaceutical products are typically used in a clinical setting.
Basic computer and software skills.
Must be able to communicate effectively with internal and external customers.
Demonstrate ability to collect, analyze and interpret complaint and adverse event information.
Qualifications :
Must be at least 18 years of age.
High School Diploma required.
Bachelors Degree in Engineering, Medical Sciences, or other related scientific field required.
2 years experience in a health care environment, and / or within a quality / compliance / regulatory organization in an FDA regulated business preferred.
US FDA Medical Device Reporting and experience with Trackwise Digital preferred.
Work Environment
This is largely a sedentary role.
This job operates in a professional office environment and routinely uses standard office equipment.
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
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