AddressSummary
The AKA RA Manager 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. The AKA RA Manager has in-depth knowledge of best practices and how their own area integrates with others; has working knowledge of competition and the factors that differentiate them in the market.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.
Job Description
Roles and Responsibilities:
AKA RA Manager is to provide 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, primarily support ANZ.
Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.
Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.
Impacts approaches, projects and programs in the functional area or affected business organization and ways of working. Impacts quality, efficiency and effectiveness of own team. These jobs have significant input into their priorities. Jobs at this level tend to be covered by professional practices and policies but these are shaped by the role. Working within broad guidelines and policies, roles at this level have moderate autonomy, requiring high levels of evaluative judgment.
Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.
Required Qualifications:
This role requires significant experience in the Quality & Regulatory Affairs.
Knowledge level is comparable to a Master's degree from an accredited university or college ( or a high school diploma with relevant experience).
Desired Characteristics:
Strong oral and written communication skills.
Strong interpersonal and leadership skills.
Demonstrated ability to analyze and resolve problems.
Demonstrated ability to lead programs / projects.
Ability to document, plan, market, and execute programs.
Established project management skills.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
Flexible working options and flexible hours
Competitive salary
5 weeks leave (ask about "take 5")
Generous leave & family policies
Long term career opportunities (locally and globally)
Generous discounts for goods & services via our employee benefits program (think travel, entertainment & shopping!) *This was recently rated as one of our employees favourite benefits!
Women and indigenous candidates are strongly encouraged to apply. Please note that to be considered for this position you must have unrestricted working rights for Australia and be prepared to undergo a background check which includes a police check. All GE HealthCare employees are required to be fully vaccinated for Covid-19.
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Additional Information
Relocation Assistance Provided: No
