Safety Regulatory Reporting and Global Complaints Analyst
2 weeks ago
Duration: 6 Months Contract
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
Experience:
2+ years experience in a health care environment, and/or within a quality/compliance/regulatory organisation
Required Skills:
Must be able to communicate in English.
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 organisation.
US FDA Medical Device Reporting and experience with Trackwise Digital preferred.
Managing device complaints and adverse events globally
Education:
Bachelors Degree in Engineering, Medical Sciences, or other related scientific field required
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
Recruiter Details:
Name: Mirza
Email: Teamzebra@ustechsolutions.com
Internal Id: 24-10118
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