Job Information
GE Healthcare ANZ RA Director in Mascot, Australia
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 in ANZ. Interprets simple internal and external business challenges and recommends best practices to improve products, processes or services. Stays informed of industry trends that may influence work.
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.
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Job Description
Roles and Responsibilities
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 in ANZ such as TGA and Medsafe.
Establishes monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies.
Requires specialized depth and/or breadth of expertise within their discipline. May require strong commercial awareness and is expected to influence the development of strategy within own area, including control of resources and influences policy formulation.
May lead functional teams or projects with minimal resource requirements, risk, and/or complexity. Communicate difficult concepts and may influence others’ opinions on particular topics. May guide others to consider a different point of view.
Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.
Uses high level of judgment to make decisions and handle complex tasks or problems that impact the function. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
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.
15+ years of experience in leading medical device companies in leadership positions, experience working with regulatory agencies and notified bodies is a must. Experience in advocacy is considered a bonus.
Proficiency in English - reading and good writing skills
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.
GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, colour, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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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