Regulatory Affairs Specialist DB Healthcare, Inc. Covington GA
Regulatory Affairs Specialist
DB Healthcare, Inc.
Health Care, Legal, QA - Quality Control
Top Required Skills:
· Knowledge of the U.S, European and international medical device regulations
· Experience in collecting data from different sources including document management systems (such as Mastercontol and Trackwise)
· Strong Microsoft Office Skills, especially Excel, SharePoint and Onedrive
· Working experience with cross functional teams including R&D, Operations, Quality and Manufacturing sites
· Demonstrates working knowledge of healthcare-related regulations.
· Demonstrates in-depth knowledge of preparing a submission. Demonstrates in-depth knowledge of industry and competitive products.
· Applies relevant regulations and statutes to further product submissions of basic to medium complexity.
· Contributes to the strategic direction of regulatory pathway development. Refines and conforms the preliminary data used in the submission process.
· Translates technical data and descriptions into reviewer-friendly content.
· Helps to ensure that the appropriate regulatory requirements for the submission are met.
· Interacts with regulatory body to help further product approvals or clearance.
· Has in-depth experience, knowledge and skills in own job family
· Applies knowledge and skills to a wide range of standard and non-standard situations Works independently with minimal guidance
· Usually determines own work priorities
· Acts as a resource for colleagues with less experience
· Able to follow up with RA specialists and associates on data requests needed to support data collection needs
· Detail-oriented and analytical with demonstrated ability to extract insight from data
About DB Healthcare IT
DB Healthcare partners with information technology groups within various healthcare organizations and established consulting practices to provide them with qualified consulting staffing resources. More jobs available at http://www.dbhealthcare.com.
Title: Regulatory Affairs Specialist - GA
Location: Covington GA 30014
Duration: Contract Ð 3 Months
Start Date: ASAP
· Local candidates only.
· W2 only; no visa holders or candidates through C2C vendors
Job Description - Summary:
The client is building a regulatory registration database and requires all the appropriate regulatory data to be collected and prepared for upload. They need a Regulatory Aaffairs resource to help collect, organize and verify regulatory data for the Urology and Critical Care Business Unit. The Regulatory Affairs is responsible for planning, coordinating and implementing regulatory strategies for products that require government approval.
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