What are the responsibilities and job description for the Regulatory Affairs Specialist position at TekOne IT Services Pvt. Ltd.?
Role: Regulatory Affairs Specialist
Location: Columbus, OH
Duration: 06 Months
Job Description / Responsibilities
Location: Columbus, OH
Duration: 06 Months
Job Description / Responsibilities
- Supports execution of External Regulations Standards and Guidance Documents packages through tracking and monitoring ePAS packages from draft to final closure
- Prepares metrics associated with the process for Executive Management Review (EMR)
- Completes final signature approval of an ePAS package (i.e., FSG Approval)
- Data review, analysis, and verification.
- Manager regulatory submissions to ensure timely regulatory approval of medical devices.
- Monitor changing regulations in geographies and translate/communicate these requirements to project development and/or continuous improvement project teams.
- Ensure all client products and procedures comply with applicable regulatory agency requirements and guidelines.
- BS in engineering or scientific degree
- 2-4 years of experience in a medical device or similarly regulated industry
- Strong analytical and problem-solving skills.
- Demonstrated competency and working knowledge of Excel, Word, PowerPoint, SharePoint, and Teams.
- Communicate effectively verbally and in writing.
