Optum · 13 hours ago
Regulatory Affairs Analyst - Remote
United States
Full-time
Remote
Entry, Mid Level
$71K/yr - $127K/yr
2+ years expOptum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The Regulatory Affairs Analyst is responsible for ensuring that products comply with relevant medical device regulations and standards, while also providing support in regulatory submissions and training business unit employees.
EducationHealth CareMedicalPharmaceutical
Responsibilities
Assists in identify, analyze and perform research on all applicable medical device regulations and standards for the regions in which the company does business, including United States, Canada, Europe, UK, Australia and other markets IWS intends to market
Provides subject matter expertise in the interpretation of applicable medical device regulations and standards as they apply to the company products, processes, and procedures
Provides necessary product development support in the following regulatory affairs activities:
Reviews product artifacts that require regulatory affairs oversight to ensure compliance with applicable medical device regulations and standards, including product labeling
Reviews changes to existing products and provide recommendation as to whether a new/revised submissions, registrations, licenses or certificates are required
Develops and maintains regulatory deliverables for each product by actively participating as team member on all assigned new product releases
Create and implement regulatory plans to ensure all requirements are met for applicable markets in a timely manner
Provides necessary support in regulatory submissions, license applications and device listings and registrations as required
Provides necessary support in training, advises and coaches business unit employees to ensure compliance with all applicable standards and regulations
Supports internal and external audits and inspections, as required by the business unit
Provides necessary support in establishing and implementing procedures for regulatory affairs activities for compliance with applicable medical device regulations and standards
Provides necessary support in investigations and resolving compliance problems or questions received from other units of the company, customers, regulatory agencies and other sources, as required
Qualification
Required
2+ years of quality systems experience in medical device industry or an ISO 13485 / 9001 regulated industry, or equivalent
2+ years of experience with medical device regulations and standards, including: ISO 13485 Medical Device Quality System Requirements, ISO 14971 / EN ISO 14971 Medical Device Risk Management, U.S. FDA Quality System Regulation (21 CFR 820), Canadian Medical Devices Regulations (SOR/98-282), European Medical Device Directives / Regulations
Ability to travel up to 10% when required
Preferred
Experience in a software development industry
All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy
Benefits
Comprehensive benefits package
Incentive and recognition programs
Equity stock purchase
401k contribution
Company
Optum
Optum is a healthcare company that provides pharmacy services, health care operations, and population health management. It is a sub-organization of UnitedHealth Group.
10001+ employees
Funding
Current Stage
Late StageLeadership Team
Daniel Castillo
Chief Executive Officer, Optum Care Delivery
J
Jay Green
Chief Financial Officer
Recent News
2025-11-29
2025-11-19
2025-11-07
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