Integer Regulatory Affairs Specialist in Plymouth, Minnesota
The primary purpose of this job is to execute and provide input on regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets, and ensure compliance with relevant FDA, EU, ISO, and other regulatory requirements and standards.
Key Accountabilities and Responsibilities
1.Adheres to Integer Core Beliefs and all safety and quality requirements.
2.Develops international regulatory strategies for product submissions, identifying and tracking international requirements.
3.Works with minimal consultation/guidance from senior department members, participates on Product Development teams, providing input in regulatory, strategy, timelines, and direction.
4.Assists in the preparation of US and International submissions and works with government agencies and/or distributors to obtain product approval/clearance.
5.Serves as informational resource for all departments, assisting in keeping company informed of US and International regulatory requirements. Ensures relevant International, ISO and FDA Export requirements are met, as required and ensures accuracy of submission information.
6.Initiates FDA export approval requires and product release authorizations.
7.Reviews ECO’s and assess effect of product changes on US and International regulatory strategy and submissions per standard procedures.
8.Assists with recall/retrieval documentation and other activities.
9.Develops and maintains regulatory status documents and submission procedures and international regulatory requirements database.
10.Assists senior staff with implementation of new methodologies associated with product quality and quality systems.
11.Performs other functions as required.
•Minimum Education: Bachelor’s degree in a related field.
•Minimum Experience: Minimum 5 years of experience in organizing and accurately controlling large amounts of detailed information with 0-3 years of US and International medical device industry experience preparing documents for regulatory submission/approval.
•Specialized Knowledge: Experience with class III/Implantable devices desired. Knowledge of FDA Quality System regulations and ISO requirements and documents.
•Special Skills: Ability to work in a team environment. Highly organized and able to work on and track multiple project simultaneously. Excellent written and oral communications, Ability to communicate effectively with individuals speaking multiple languages.
•Other: Ability to research current international requirements. Ability to address concurrent demands from multiple sources. Skill in working with computers and experience with spreadsheet and word-processing software.
- Employee Type: Full-Time
- Location: Plymouth,MN
- Job Type: QA - Quality Control
- Experience: At least 5 year(s)
- Date Posted: 5/19/2017