2 safety regulatory reporting and global complaints analyst Jobs in plymouth, mn
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Analyst, Safety Regulatory Reporting and Global Compliants
$75k-99k (estimate)
Full Time | Business Services
5 Days Ago
LanceSoft Inc is Hiring an Analyst, Safety Regulatory Reporting and Global Compliants Near Plymouth, MN
Title : Analyst, Safety Regulatory Reporting and Global ComplaintsLocation : 6000 Nathan Lane N, Plymouth, MN 55442 United StatesDuration : 6 Months contractQualificationsJob description:
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
- 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.
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.
- 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.
Job Summary
JOB TYPE
Full Time
INDUSTRY
Business Services
SALARY
$75k-99k (estimate)
POST DATE
06/02/2024
EXPIRATION DATE
06/21/2024
WEBSITE
lancesoft.com
HEADQUARTERS
HERNDON, VA
SIZE
500 - 1,000
FOUNDED
2000
TYPE
Private
CEO
DIVYA GANDHI
REVENUE
$200M - $500M
INDUSTRY
Business Services
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About LanceSoft Inc
LanceSoft is a provider of application development, management outsourcing and data-warehousing services to the aerospace and automotive sectors.
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