Regulatory Affairs Specialist

Job description

Job Number

2847556

Business

GE Healthcare

Business Segment

Healthcare Quality

About Us

GE Healthcare provides transformational medical
technologies and services to meet the demand for increased access, enhanced quality and more affordable
healthcare around the world. GE works on things that matter - great people and technologies taking on tough
challenges. From medical imaging, software & IT, patient monitoring and diagnostics to drug discovery,
biopharmaceutical manufacturing technologies and performance improvement solutions, GE Healthcare helps
medical professionals deliver great healthcare to their patients..
GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer . Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Posted Position Title

Regulatory Affairs Specialist

Career Level

Experienced

Function

Quality

Function Segment

Regulatory Affairs

Location(s) Where Opening Is Available

United States

U.S. State, China or Canada Provinces

Wisconsin

City

Waukesha

Postal Code

53188-1696

Relocation Assistance

No

Role Summary/Purpose

This position works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of pre- and post-market regulations, submissions and new product development.

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.

Additional Eligibility Qualifications

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a background investigation and drug screen.

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 fast-paced 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

Desired profile

Qualifications/Requirements

1. Bachelor's Degree or a minimum of 3 years work experience. 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