Regulatory Specialist II

Imricor Medical Systems Inc•Burnsville, MN

2d•$80,000 - $110,000•Onsite

About The Position

The Regulatory Specialist II is responsible for supporting creation, development, and implementation of regulatory submissions to the EU notified body, the US FDA, and other country specific regulatory bodies. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

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.

Responsibilities

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.