The Regulatory Affairs Specialist for Ultrasound Product
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.
Key responsibilities include:
•File and maintain regulatory deliverables.
•Create the 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.
•Communicate license approvals when received.
•Review changes in existing products to determine need for
new/revised submissions or document reason for no submission
•Communicate changes in existing products to Region RA for
determination of the need for new/revised licenses or registrations; partner
with Region RA for countries with license expiration requirements; 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
•Support regulatory inspections as required
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.Ensure assigned regulatory submissions are accurate,
complete and timely
5.Maintain up-to-date knowledge and understanding of current
regulatory requirements within area of responsibility
1.Bachelor's Degree (or international equivalent) in a
related field such as: Regulatory Science, Biomedical Engineering, Biology,
Chemistry, English (with a technical writing emphasis), Legal Studies, Law,
Nursing, Physician Assistance, Pharmaceutical Science, Pharmacy OR minimum of 4
years progressive regulatory affairs experience in medical device or
pharmaceutical industry or medical product regulation agencies, including
knowledge and experience applying drug or device laws and regulations
2.Strong analytical skills
3.Ability to work in a team environment with minimal
supervision on projects and activities
4.Ability to prioritize, plan & evaluate deliverables
5.Knowledge & experience conducting scientific,
regulatory, legal, or business research.
6.Excellent verbal and written communication and
presentation skills with the ability to communicate in English in an easy to
7.Experience using spreadsheet and presentation software
1.Advanced degree in scientific, technology or legal
2.Regulatory Affairs Certification (RAPS).
3.Experience in a medical device or pharmaceutical industry.
4.Knowledge of Quality Management Systems (QMS).
5.Experience working across cultures/countries/sites.
6.Demonstrated experience interfacing with regulatory
agencies (e.g. FDA, MHLW, Health Canada, CFDA, KFDA, etc.) and standards bodies
such as AAMI, IEC, ISO, UL.
7.Demonstrated experience prioritizing conflicting demands
from multiple business entities in an extremely fast paced environment.
8.Demonstrated understanding of healthcare environment and
knowledge of current competitive, commercial or political situations and their
impact on GEHC regulatory strategies.
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
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