9 days old

Regulatory Affairs Specialist - PDx (Contractor)

GE Energy
Role Summary:The RA Specialist (Contractor) will work within a team of Regulatory Affairs professionals in the Pharmaceutical Diagnostics (PDx) division of GE Healthcare Korea. He/she will ensure contribute in establishing best practices in the area of pre- and post-market regulations, submissions and new product development. This is a fixed-term contract position for 1 year.

Essential Responsibilities:1.Maintains records on legislation, regulations and guidelines

2. Investigates regulatory history of similar products to assess approval implications

3. Conducts research on submission requirements and options

4. Assists in monitoring and reporting project timelines

5. Responds to RA information requests

6. Communicates license approvals when received.

7. Organizes materials from preclinical and clinical studies for review and assist in review process

8. Coordinates and assists in the preparation of submission packages for regulatory agencies

9. Assists in the review of advertising and promotional items

10. Supports regulatory inspections as required

11. Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Qualifications/Requirements:1. Bachelor's Degree or a minimum of one year work experience preferred.

2. Ability to communicate effectively in English (both written and oral).

3. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Quality Specific Goals:

1. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.

2. Complete all planned Quality & Compliance training within the defined deadlines.

3. Identify and report any quality or compliance concerns and take immediate corrective action as required

Desired Characteristics:1. Minimum of 1 year experience in a regulated industry is preferred

2. Advanced degree in scientific, technology or legal disciplines

3. Statistics education and or training

4. Ability to work independently in fastpaced environment with little supervision.

5. Ability to adapt to constant change and influence positive change effectively.

6. Team-oriented and responsive to customer needs.

7. Attention to Detail and Results-Oriented.

8. Ability to understand technical documentation and execute associated procedures

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GEs mission and deliver for our customers. www.ge.comAdditional Locations:Korea, Republic of;Seoul;


Posted: 2020-09-08 Expires: 2020-10-08

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Regulatory Affairs Specialist - PDx (Contractor)

GE Energy

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