Senior Regulatory Specialist
About The Position
The Senior Regulatory Specialist plans, manages, and implements regulatory submissions to the EU-notified body, the US FDA, and other country-specific regulatory bodies. The role helps ensure continued compliance with regulatory agency approvals, including through change impact reviews. It also requires compliance with the Imricor Quality Management System and the company’s environmental, health, and safety policies. The position develops regulatory approval strategies and coordinates regulatory filings for new and modified products. It provides regulatory leadership and technical review across product development, manufacturing, clinical support, and other cross-functional projects, while supporting medical device reporting and regulatory vigilance activities. The role works with minimal supervision to meet defined goals and objectives.
Requirements
- Bachelor of Science in a scientific discipline or equivalent education or training.
- At least 5 years of Regulatory and/or Compliance-related experience in a regulated industry.
- Previous experience with U.S. and EU medical device regulatory requirements, including Quality Systems and clinical investigations standards.
- Experience preparing, submitting, and obtaining approval for medical devices.
- Strong verbal and written communication skills.
- Strong analytical and problem-solving skills and a good background in the medical device development process.
- Demonstrated ability to manage multiple projects and priorities effectively.
- Skills using computer-based tools and software such as Word, PowerPoint, Excel, and Adobe Acrobat.
- Ability to meet the stated working-condition requirements: near vision at 20 inches or less, ability to identify or distinguish colors, and ability to type, talk, and hear.
- Must be able to work in the Burnsville, Minnesota office.
Nice To Haves
- EU MDR transition experience.
- Experience with Australian regulations.
Responsibilities
- Develop domestic and international strategies for regulatory approval of company products.
- Coordinate, compile, and submit 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.
- Develop and maintain positive relationships with regulatory body reviewers through oral and written communications, including clarification and follow-up of submissions under review.
- Review product and manufacturing changes for compliance with applicable regulations and their impact on regulatory filings.
- Represent Regulatory Affairs on cross-functional product development, manufacturing, and clinical support teams; provide regulatory leadership and feedback throughout product development and recommend ways to overcome regulatory barriers.
- Provide technical reviews of supporting documentation for regulatory filings.
- Support Medical Device Reporting (MDRs) and Medical Device Vigilance Reporting.
- Represent Regulatory Affairs on other cross-functional projects, which may include process changes and continuous improvement efforts.
- Meet defined goals and objectives through personal initiatives, activities, and available resources with minimal supervision.
- Comply with Imricor Quality Management System requirements and carry out responsibilities under environmental, health, and safety policies.
- Perform other related duties and responsibilities as assigned.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Health Savings Accounts
- Health Care and Dependent Care Flexible Spending Accounts
- Disability benefits
- Life insurance
- Retirement benefits
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What This Job Offers
Job Type
Full-time
Career Level
Senior
