Regulatory Operations Specialist chez 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 $55,000- $89,000. 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 Operations Specialist is responsible for assisting in the preparation and submittal of regulatory documentation to agencies such as the FDA, EU Notified Bodies, and other global regulatory authorities. Also, this position is responsible for certification management with agencies. 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

· Assists in preparing and submitting regulatory filings for new and existing products.

· Supports regulatory strategies for domestic and international approvals.

· Manages the UDI (Unique Device Identification) databases in the US and EU.

· Manages product registrations and device listings to ensure timely approvals.

· Assists with technical and labeling reviews for regulatory submissions.

· Supports cross-functional teams to ensure regulatory requirements are met throughout the product development process.

· Acts as a Relationship Coordinator for managing economic operators.

· Supports certification management by maintaining compliance with regulatory agency requirements.

· Performs other related duties and responsibilities, as assigned.

Requirements

Qualifications

• Bachelor of Science Degree in scientific discipline or an equivalent combination of education or work experience.
• 1-3 years’ regulatory-related experience in the regulatory industry.  Internship or academic experience in regulatory affairs, compliance, or a related area a plus.
• 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.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• Requires typing, talking, and hearing.
• 85% of the time requires viewing and working on a computer screen.

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions