Regulatory Affairs Specialist
- GE Healthcare
- Posted 7/26/2017 5:39:05 PM
- Job Function: Quality
- Business Segment: Healthcare Quality
Location(s): India; Bangalore
GE is the world's Digital Industrial Company, transforming industry with software-defined machines and solutions that are connected, responsive and predictive. Through our people, leadership development, services, technology and scale, GE delivers better outcomes for global customers by speaking the language of industry.
GE is an equal opportunity employer and supports Diversity.
The lead Regulatory affairs works as a Mentor on the subject matter of Regulatory affairs. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes Standard Methodologies in the area of pre market regulations, submissions and new product development.
1. Finds, gathers and maintains the information and documents required for the product registration files submitted to regulatory agencies and as per the projects timelines.
2. Contributes to writing and editing technical documents
3. Understands and applies regulatory requirements and their impacts for submissions
4. Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions
5. Supports all assigned new product introductions and country submission projects as applicable.
6. Interfaces with the applicable RA representatives to confirm the requirements and the impact of changes in existing products for determination of the need for new/revised licenses or registrations.
7. Understands the regulatory affairs activities related to the new product development, to the advertising and promotion and to the post market.
8. Participates with the applicable RA representatives, and for countries with license expiration requirements, to the plans, deliverables and timely submission for renewal of license.
9. Ensures compliance with premarket product approval requirements
10. Supports regulatory inspections as required.
11. Performs a broad variety of tasks in support of product and region requirements as assigned by the departmental Leadr.
12. Maintains dashboards of activities and provides data for metrics.
13. Participates to the constant improvement of the premarket activities.
Quality Specific Goals:
1. Aware of and follow 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
1. Bachelor's Degree or a minimum of 4 years work experience. 2. Minimum of 1 year experience working in a regulated industry or a Masters degree 3. Ability to communicate effectively in English (both written and oral). 4. Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications. Quality Specific Goals: 1. Aware of and follow 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
1. Minimum of 4 years’ experience in a regulated medical device industry is preferred
2. Advanced degree in scientific, technology or legal disciplines
3. Regulatory Affairs Certification (RAPS)
4. Statistics education and or training
5. Ability to work independently in fast-paced environment with little supervision.
6. Ability to adapt to constant change and influence positive change effectively.
7. Team-oriented and responsive to customer needs.
8. Attention to Detail and Results-Oriented.
9. Ability to understand technical documentation and execute associated procedures
Locations: India; Bangalore