Regulatory Affairs Analyst - Remote

Optum is a global organization that delivers care, aided by technology to help millions of people live healthier lives. The work you do with our team will directly improve health outcomes by connecting people with the care, pharmacy benefits, data and resources they need to feel their best. Here, you will find a culture guided by inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health optimization on a global scale. Join us to start Caring. Connecting. Growing together.

The Regulatory Affairs Analyst is responsible for assuring that products developed by the company and supporting business processes comply with relevant current medical device regulations in the countries in which the company does business. The position involves being able to influence, but not direct, the activities of many people across the entire company who report to other managers.

You'll enjoy the flexibility to work remotely * from anywhere within the U.S. or Canada as you take on some tough challenges. For all hires in the Minneapolis or Washington, D.C. area, you will be required to work in the office a minimum of four days per week.

Primary 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

• 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

• Experience in a software development industry