Regulatory Affairs Senior Consultant - Remote

Requisition Number: 2352126
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 diversity and inclusion, talented peers, comprehensive benefits and career development opportunities. Come make an impact on the communities we serve as you help us advance health equity on a global scale. Join us to start Caring. Connecting. Growing together.
The Regulatory Affairs Senior Consultant - Remote 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. 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
• 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

You'll be rewarded and recognized for your performance in an environment that will challenge you and give you clear direction on what it takes to succeed in your role as well as provide development for other roles you may be interested in.
Required Qualifications:

• 8+ years of quality systems experience in medical device industry or an ISO 13485 / 9001 regulated industry, or equivalent
• 8+ 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 Qualification:

• Experience in a software development industry

*All employees working remotely will be required to adhere to UnitedHealth Group's Telecommuter Policy.
Pay is based on several factors including but not limited to local labor markets, education, work experience, certifications, etc. In addition to your salary, we offer benefits such as, a comprehensive benefits package, incentive and recognition programs, equity stock purchase and 401k contribution (all benefits are subject to eligibility requirements). No matter where or when you begin a career with us, you'll find a far-reaching choice of benefits and incentives. The salary for this role will range from $91,700 to $163,700 annually based on full-time employment. We comply with all minimum wage laws as applicable.
Application Deadline: This will be posted for a minimum of 2 business days or until a sufficient candidate pool has been collected. Job posting may come down early due to volume of applicants.
At UnitedHealth Group, our mission is to help people live healthier lives and make the health system work better for everyone. We believe everyone-of every race, gender, sexuality, age, location and income-deserves the opportunity to live their healthiest life. Today, however, there are still far too many barriers to good health which are disproportionately experienced by people of color, historically marginalized groups and those with lower incomes. We are committed to mitigating our impact on the environment and enabling and delivering equitable care that addresses health disparities and improves health outcomes - an enterprise priority reflected in our mission.
UnitedHealth Group is an Equal Employment Opportunity employer under applicable law and qualified applicants will receive consideration for employment without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
UnitedHealth Group is a drug - free workplace. Candidates are required to pass a drug test before beginning employment.