General Electric Regulatory Affairs Leader, Thailand in Thailand
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. Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
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
Utilizes in-depth knowledge of a discipline and analytical thinking to execute policy/strategy. Basic knowledge of related job disciplines.
Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.
Jobs at this level function with some autonomy but are subject to functional practices and precedents or are covered by well-defined policies or review of end results. The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
Uses some judgment and has the ability to propose different solutions outside of set parameters to address more complicated, day-to-day problems. Has ability to prioritize information for data analysis. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own team to arrive at decisions.
This role requires advanced 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).
Proficiency in English - reading and good writing skillsAbility to clearly communicate in a simple way that is easy to understand
Min. 3-5 years experience in a regulated industry in QA / RA / similar functions
Ability to use written and oral communication tools, in person and remotely.Effective use of multiple communication tools to convey messages and need - phone, in person, messaging, email etc•Able to tailor communication path to better meet the needs of the situation
Ability to learn regulations effectively• Working knowledge of country/region regulations and standards• Able to identify and monitor for changes to requirements• Applies several sets of requirements together balancing strategy effectively•Ability to interpret changes in regulation, environment, impact & communicate in a timely and effective manner.•Ability to generate clear and detailed assessments of regulations and rationales with convincing and logical arguments for why something is in compliance with the regulation. •Deep expertise in one or more regulatory expertise areas in order to be the broader team "expert" in these areas. With supervision, review Advertising and promotional material
Relocation Assistance Provided: No