Global Medical Device Regulatory Specialist

Imricor Medical Systems; Burnsville (MN); On-site; USD 100,000 - 130,000; Full time

Job summary

Imricor Medical Systems in Burnsville, MN seeks a Senior Regulatory Specialist to plan, manage and implement regulatory submissions to the US FDA, EU Notified Body, and other authorities. This role ensures continued compliance with regulatory approvals and the Imricor Quality Management System.

You will coordinate filings for PMAs, 510(k)s, IDEs, CE Marking submissions, and other registrations, lead cross-functional teams, and provide regulatory leadership throughout product development.

Qualifications

• Bachelor of Science in a scientific discipline or equivalent education/training.
• 5+ years regulatory/compliance experience in a regulated industry.
• Experience with US and EU medical device regulatory requirements including Quality Systems and clinical investigations standards.
• EU MDR transition experience preferred.
• Australian regulations experience preferred.
• 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.

Responsibilities

• 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 registrations.
• Maintains relationships with regulatory reviewers through communication regarding submissions under review.
• Reviews product and manufacturing changes for compliance and impact on filings.
• Provides regulatory leadership on cross-functional teams throughout product development.

Skills

Communication

Analytical thinking

Project management

Regulatory knowledge

Education

Bachelor of Science in a scientific discipline

Tools

Word

PowerPoint

Excel

Adobe Acrobat

Job description

Imricor Medical Systems in Burnsville, MN seeks a Senior Regulatory Specialist to plan, manage and implement regulatory submissions to the US FDA, EU Notified Body, and other authorities. This role ensures continued compliance with regulatory approvals and the Imricor Quality Management System.

You will coordinate filings for PMAs, 510(k)s, IDEs, CE Marking submissions, and other registrations, lead cross-functional teams, and provide regulatory leadership throughout product development.