Regulatory Specialist II bei Imricor Medical Systems Inc

Description

Supervisor’s Title: VP of Regulatory and Quality  
Exempt or Non-Exempt: Exempt

Location: Must be able to work at the Burnsville, MN office.

Compensation: The expected base salary for this Minnesota-based position is $80,000-110,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function 

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.

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.

Requirements

Qualifications

• 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.