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Regulatory Specialist II

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Imricor Medical Systems

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Location:
United States , Burnsville

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Category:
IT - Administration

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Contract Type:
Not provided

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Salary:

80000.00 - 110000.00 USD / Year
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Job Responsibility:

  • Supports domestic and international strategies for regulatory approval of company products
  • Assists in coordination, compilation and submission of U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations
  • Reviews product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
  • Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle
  • Completes technical and labeling reviews of supporting documents for inclusion in regulatory filings
  • Represents RA on other cross functional projects which may include process changes and continuous improvement efforts
  • Performs other related duties and responsibilities, as assigned

Requirements:

  • Bachelor of Science in a scientific discipline or equivalent education/ training
  • 2-4 years’ regulatory related experience in a regulatory industry. Additional education may be substituted for years of experience
  • Demonstrated ability to communicate complex ideas clearly and simply both orally and in writing
  • Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat
  • Must be able to work independently under limited supervision
What we offer:
  • Medical
  • Dental
  • Vision
  • Health Savings Accounts
  • Health Care & Dependent Care Flexible Spending Accounts
  • Disability Benefits
  • Life Insurance
  • Retirement Benefits

Additional Information:

Job Posted:
May 14, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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