Overview
On Site
USD 50-53
Full Time
Contract - W2
Contract - Independent
Contract - 6 Month(s)
Skills
Project Managers
Compliance
Jurisdiction
Electronic Products
Regulatory Compliance
Risk Management Tools
Medical Compliance
Identifying Issues
Nuance
Excel
SQL
Job Details
JOB TITLE: PROJECT MANAGER (ELECTRONIC COMPLIANCE)
JOB DURATION: 6-8 MONTHS (CONTRACT TO HIRE FULLTIME)
JOB LOCATION: IRVING, TX | ARLINGTON, TX | SEATTLE, WA (ON-SITE)
EXPERIENCE: 8+ YEARS
VISA: , GC-EAD - CAN APPLY. - (NO H1B)
Interview process -
- 2 interviews, behavioral and team interview
- The majority of the time zone 7 am CST - 3-4 CST (flexible)
Job Description
Responsibilities
- Onboarding of new program launch in new jurisdictions, compliance, inception of product, register to SOPs, scope, and submitting reports to regulators.
- Identifying regulations we are responsible for, given the subset of counties to research the compliance requirements, if compliant, assure registration and pull reports
- Major kpi is time to launch, once we find the regulation, time to onboard and complete, will launch about 30-35 programs during 6 months for a small subset of devices.
- Team is global (America and Asia)
- Manage 150 different programs across America and an Asia-specific subset inside the devices team.
- Disqualifies - risk manager, has to be in compliance with risk. Financial compliance isn't the same either
Must Have:
- 2+ years of experience working with electronic/device compliance (or in a similar field such as medical, environmental compliance)
- actually done the reporting of the regulation to the regulator
- 1+ years of PM experience within regulatory compliance/reporting (ensure compliance for project launches)
- Ability to prioritize, familiar with RICS management and ability to identify top risk
- Excellent organization, prioritization, and hitting timelines, ensuring on-time product launch
- Strong data analysis and understanding of nuances within the regulations
- Strong experience with Excel, being able to understand large data sets
Plusses:
- Worked on a global team (Australia, Japan, Asia, etc.)
- SQL is a plus
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