The Global Regulatory Affairs (RA) Leader provides subject matter expertise. He/she works within a team of Regulatory Affairs professionals to ensure GEHC establishes best practices in the area of premarket regulatory submissions and new product development globally. Essential Responsibilities Create regulatory compliance / project plan using Regulatory Intelligence and in collaboration with Region RA to ensure all requirements are met for country submissions; work with relevant personnel to ensure appropriate, timely input is provided for submissions.
Create and file submissions; communicate with authorities regarding these submissions.
If specific country testing is needed, work with Region RA, and arrange for test devices and support as needed.
Review and approve advertising and promotion material ensuring it is consistent with approved claims for regulated products.
Review changes in existing products to determine need for new/revised submissions or document reason for no submission
Educate, train, & advise company professionals to ensure compliance with regulatory requirements
Communicate changes in existing products to Region RA representatives for determination of the need for new/revised licenses or registrations.
Partner with Region RA representative for countries with license expiration requirements, to establish plan and deliverables for timely submission for renewal of license.
Identify any clinical data requirements for product licensing globally and insure the requirements are documented in the compliance plan.
Provide RA oversight to clinical studies.
Support regulatory inspections as required.
Coach or mentor other RA professionals.
File / maintain regulatory deliverables
Actively participate as team member on all assigned new product introductions
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
4. Maintain up-to-date knowledge and understanding of current regulatory requirements within area of responsibility.
5. Effectively support implementation & management of current regulatory requirements within area of responsibility.
6. Ensure assigned regulatory submissions are accurate, complete and timely.
1. Bachelor's Degree (or internationally recognized equivalent) & minimum of 3 years experience in the pharmaceutical industry or with regulatory agencies; OR minimum of 7 years progressive regulatory affairs experience in pharmaceutical industry or with regulatory agencies, including knowledge & experience applying drug laws & regulations for product registration
2. Ability to prioritize, plan & evaluate deliverables to established strategic goals.
3. Proven application of analytical skills in a regulatory environment
4. Excellent verbal and written communication and presentation skills with the ability to communicate business issues in English in an easy to understand manner.
5. Demonstrated knowledge & experience conducting scientific, regulatory, legal, or business research.
6. Strong problem solving and negotiation skills
7. Ability to work well independently & in a team setting.
8. Prior experience using spreadsheet and presentation software.
9. Must be willing to travel up to 10% of time. 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. Advanced degree in scientific, technology or legal disciplines.
2. Regulatory Affairs Certification (RAPS).
3. Demonstrated experience interfacing with regulatory agencies (e.g. FDA, MHLW, Health Canada, KFDA, etc.) and standards bodies such as AAMI, IEC, ISO, UL.
4. Knowledge of Quality Management Systems (QMS)
5. Experience with working across cultures/countries/sites
6. Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
7. Demonstrated understanding of healthcare environment and knowledge of current competitive, commercial or political situations and their impact on GE Life Sciences regulatory strategies.