Senior Regulatory Specialist Jobs

Imricor Medical Systems

Location:
United States, Burnsville

Category:
Quality Control

Contract Type:
Not provided

Salary:

100000.00 - 130000.00 USD / Year

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Job Description:

The Senior Regulatory Specialist is responsible for planning, managing, and implementing regulatory submissions to the EU-notified body, the US FDA, and other country-specific regulatory bodies. This position ensures continued compliance with regulatory agency approvals including change impact reviews. This position is also responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Job Responsibility:

Develops domestic and international strategies for regulatory approval of company products
Coordinates, compiles, and submits 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
Develops and maintains positive relationships with regulatory body reviewers through oral and written communications regarding clarification and follow-up of submissions under review
Reviews product and manufacturing changes for compliance with applicable regulations and impact on regulatory filings
Represents RA on cross-functional product development, manufacturing, and clinical support teams and provides regulatory leadership and feedback throughout the product development cycle. Provides recommendations for how to overcome regulatory barriers
Provides technical reviews of supporting documentation for inclusion in regulatory filings
Supports Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting
Represents RA on other cross-functional projects, which may include process changes and continuous improvement efforts
Meets defined goals and objectives through own initiatives, activities, and available resources with minimal supervision
Performs other related duties and responsibilities, as assigned

Requirements:

Bachelor of Science in a scientific discipline or equivalent education/ training
5+ years’ Regulatory and/or Compliance-related experience in a regulated industry
Previous experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards
Experience with preparation, submission, and approval for medical devices is required
Strong communication skills, both verbal and written
Strong analytical and problem-solving skills, as well as a good background in the medical device development process
Demonstrated ability to effectively manage multiple projects and priorities
Skills in multiple computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat

Nice to have:

EU MDR transition experience preferred
Australian regulations experience preferred

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:
December 09, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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Senior Regulatory Specialist