Regulatory Affairs Specialist

Job description / Role

Job Description Summary

Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Developing conceptual knowledge of professional discipline. May include support roles with specialized expertise or technical knowledge in broad area.

Job Description

Roles and Responsibilities

GEHC ONLY
- Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
- Applies general knowledge of business developed through education or past experience. Understands how work of own team contributes to the area.
- Resolves issues using established procedures.
- Consults People Leader or more senior team members for issues outside of defined parameters.
- Collaborates with others to solve issues. For customer facing roles, develops strong customer relationships and serves as the interface between customer and GE. Exchanges technical information, asks questions and checks for understanding.
- Handles simple data entry work requiring face value check and correction

Requirements

Required Qualifications

- This role requires basic experience in the Quality & Regulatory Affairs.
- Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
- Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in Job Family Group(s)/Function(s)).

Desired Characteristics

- Strong oral and written communication skills.
- Ability to document, plan, market, and execute programs.

Note:

To comply with US immigration and other legal requirements, it is necessary to specify the minimum number of years' experience required for any role based within the USA. For roles outside of the USA, to ensure compliance with applicable legislation, the JDs should focus on the substantive level of experience required for the role and a minimum number of years should NOT be used.

Additional Information

Relocation Assistance Provided: No

About the Company

GE is a diversified technology, media and financial services company, dedicated to creating products that make life better. From aircraft engines and power generation to financial services, medical imaging, television programming and oil and gas, GE operates in more than 100 countries and employs over 300,000 people worldwide.

GE's Oil & Gas business is a leader in the development and delivery of advanced product and service offerings for the global oil and gas industry. As a consequence of the rapid expansion of its technology base, GE's Oil & Gas is capable of addressing the largest and most complex engineering and application challenges entirely from its own worldwide resources. So whether it's the world's largest LNG compression trains, re-injection of high sulfur gas, enhancing the safety and productivity of the world's oil and gas pipelines, or equipment for the production of oil and gas from harsh environments, GE is leading the charge.