דרושים Director Regulatory Intelligence Policy Pdx ב-Ge Healthcare ב-Remote, Remote

Roles and Responsibilities

• Act as the single point of contact to the customer for timely and satisfactory resolution of concerns covering a wide variety of support services offered for assigned region, product, or coverage area - Responsible for knowledge of assigned region, coverage area, or product lines, their associated configuration installations, and represents the most direct access to all appropriate internal functions to support the customer · Establish and maintain contact to provide on-going technical and business support to assigned customers in designated geographic region or coverage area
• A job at this level requires a people leader with ability to hire and develop talent. Includes direct people management responsibility including staffing and performance development. Utilizes in-depth knowledge of a technical discipline and analytical thinking and technical experience to execute policy/strategy.
• 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
• Uses some judgment and has some ability to propose different solutions outside of set parameters to address more complicated manufacturing processes with technical variety and/or interdependent production cycles. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own teams to arrive at decisions.
• 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.

Required Qualifications

• For roles outside of the USA- This role requires advanced experience in the Services & Customer Service Management. Knowledge level is comparable to a Bachelor's degree from an accredited university or college ( or a high school diploma with relevant experience).
• For roles in USA - 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)).
• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

The TO will have several key functions:

Value:Define full potential, set the baseline, track progress, and maximize value creation

People:Engage the organization and inspire adoption of new behaviors and standards of performance

Anticipate and mitigate risk, manage integrated program, and orchestrate line-led execution

The Transformation Office (TO)’s role is to ensure that we:

• Maintain an integrated view of our destination and do big, transformative things
• Focus on the critical few; the TO will maintain an active backlog of attractive “next hills to climb,” we will not be in a constant state of flux and flavors of the month
• Move with pace – not letting the perfect become the enemy of the good
• Move with fluidity – we know that our roadmap will evolve as we learn; it would be a bad sign if it didn’t
• Move with consistency – while the roadmap will evolve, we will invest until the changes are installed, not spiking the ball on the 20-yard line, and will regularly evaluate when the line is ready to fully pick up the change

Challenge the status quo – don’t do things just because that is what has always been done.

Key Responsibilities:

This role will also serve as a change agent in the organization and will promote new ways of working, while heavily aligning with the Heartbeat proprietary system for how GEHC executes on the delivery of our Strategy with a Lean mindset.

Typical Responsibilities

• Facilitate team work to ensure timely deliverables
• Support team ideation with outside-in perspective
• Facilitate brainstorming and design process
• Identify and escalate risks and impediments, own team pulse check
• Liaise between team and Value, People, and Process Leads
• Advising the team on work process and new ways of working
• Helping synthesize and present team output and impediments for Transformation Office Leadership, and stakeholders in the organization
• Responsible for the efficiency of assigned initiatives
• Works with project and initiative leaders to enable and coordinate initiative teams’ ways of working, and track and manage project interdependencies
• Ensures initiative plans are achievable
• Report progress and escalate decisions and risks
• Coordinate development of risk mitigation recommendations; reconcile technology risks with execution risks

Qualifications/Requirements:

• Demonstrated program experience successfully driving large, complex improvements in prior roles
• 8+ years of experience leading in Manufacturing, Sourcing, Supply Chain, Services, Digital, Commercial or P&L
• Bachelor’s degree in a related field or equivalent required
• Strong management skills and demonstrated capability to influence
• Excellent communication and negotiation skills; strong business acumen
• Ability to effectively lead in a matrixed and virtual team environment

Desired Qualities:

• The ability to simplify and reduce issues to their fundamental causes
• Requires experience managing highly dynamic situations
• Proactive, Organized, Goal-oriented
• Adaptive, role needs to coordinate across many different stakeholders
• A good listener and a quick learner

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.

GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).

Role and Responsibilities :

• Develop and implement strategies to protect and promote GE Healthcare through engagement with Indian Federal and State Government entities, including legislative, Administrative and regulatory bodies.

• Work with GE Healthcare’s India/South Asia business leadership to ensure awareness of key issues and build GE Healthcare’s policy positions on those issues.

• Identify opportunities and threats to GE Healthcare business and utilize the function to achieve commercial opportunity for the business and to protect against threats to reimbursement and product approval opportunities.

• Shape emerging regulations and legislation to the benefit of GE Healthcare and its customers.

• Support commercial and market development opportunities identified by the businesses in which government is an instrumental decision-maker or payer.

• Work closely with GE Healthcare Public Affairs leaders to identify and deliver opportunities to position GE as a thought leader, in the field of health care technology and innovation.

• Lead and drive functional initiatives within the Government Affairs and Policy function, liaising with business and functional leaders in India/South Asia.

• Engage and lead within key India/South Asia health care trade associations to ensure GE Healthcare’s leadership on key industry issues and initiatives.

• Develop GE Healthcare India/South Asia political strategy (relationship engagement) and represent GE Healthcare at presented or created opportunities

• Work with GE Healthcare India/South Asia grassroots on employee engagement and grassroots activities.

:

• Bachelor’s degree and advanced business, technical, or law degree. Minimum 7 + years experience in government or government affairs field.

• Deep understanding of the India Federal/State health care systems.

• Experience interacting with Indian government officials within the health care space.

• Demonstrated understanding of government policy development and decision-making processes, including ability to identify and have access to key policy makers.

• Demonstrated orientation towards business growth and experience in connecting policy and business outcomes.

• Substantive understanding of key healthcare policy and business issues.

• Strong interpersonal skills and ability to advise GE business leaders.

• Proven team leader with high degree of personal initiative.

• Strong public speaking and written communication skills.

Desired Characteristics :

• Demonstrated ability to develop and execute comprehensive strategies to lead and shape complex legislative or regulatory policy matters Successful experience working on global government affairs and industry-related issues, ideally in senior leadership roles in both government and the private sector.

• Demonstrated strategic thinking, including proven ability to prioritize, balance, and meet conflicting demands from multiple business entities in a fast-paced environment.

• Commitment to conducting GE's business affairs with the highest integrity, including strict adherence to applicable laws and GE's values, which often go beyond legal compliance. Proficiency in using Microsoft Office applications such as Microsoft Word, Excel, and PowerPoint

Inclusion and Diversity

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

total rewardsare 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

Roles and Responsibilities

• Lead and manage the execution of the service strategy and plans at both regional and account level by leveraging strong customer relationships to drive growth and operational excellence.
• Drive collaboration between the different functions such as sales, operations, quality, regulatory affairs, finance, legal, procurement, logistics, etc., to ensure alignment and optimal results are achieved.
• Work closely with internal stakeholders to develop and implement new or enhanced services that differentiate GE Healthcare and meet customer needs.
• Manage and oversee the execution of service contracts including but not limited to: install base planning, project management, and revenue forecasting.
• Collaborate with Sales, Operations, Customer Experience, Finance, Legal, Procurement, Logistics, and other functions to drive commercial excellence, improve operational efficiency, reduce costs, and enhance customer experience.
• Monitor key performance indicators (KPIs) related to service and customer satisfaction, identify areas for improvement, and implement corrective actions where necessary.
• Develop and maintain relationships with key decision makers, influencers, and stakeholders within the assigned accounts and regions.
• Participate in the development of annual budgets and quarterly forecasts for the region and accounts under responsibility.
• Coordinate and lead the implementation of large projects or initiatives that impact multiple functions within the organization.
• Ensure compliance with relevant regulations, standards, and policies while promoting ethical behavior and corporate values.

Required Qualifications

• Bachelor’s degree in Business Administration, Engineering, Marketing, or equivalent, OR 15+ years of relative work experience.
• Minimum of 10 years of progressive work experience preferably in healthcare industry with a focus on services and customer/client management.
• Strong knowledge of healthcare technology products and services, particularly in medical imaging and information technologies.
• Demonstrated track record of successful leadership in customer-facing roles with increasing levels of responsibility.
• Excellent communication skills with the ability to communicate complex concepts to diverse audiences.
• Ability to influence and collaborate effectively with senior leaders, cross-functional teams, and external partners.
• Analytical mindset with the ability to interpret data and draw actionable insights.
• Project management skills with the ability to plan, prioritize, and execute against tight deadlines.
• Comfortable working in a matrix environment and navigating organizational dynamics.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Key Responsibilities:

• Sales Leadership & Business Development: Craft and implement aggressive sales strategies to pinpoint, engage, and secure new business opportunities.
• Business Development: Personally creating opportunities for qualified hospital and health system leadership who have the ability to positively influence, or make the decision to purchase GEHC Command Center programs.
• Strategic Influence: As requested, give input to help shape the business strategy.
• Stay Ahead of the Curve: Keep abreast of industry trends and competitor offerings. Interpret internal and external business dynamics, advocating best practices to refine products, processes, or services.
• Decision Making: Harness sophisticated judgment skills to navigate complex tasks or challenges in areas like operational management, product management, and consulting. Evaluate the quality and relevance of information, engage in critical questioning, and utilize a range of sources to arrive at well-informed decisions.
• Lead & Collaborate: Articulate complex concepts effectively and steer colleagues and potential clients to consider alternative perspectives.

Required Qualifications:

• A Master’s degree from an accredited university with 8 years experience or Bachelors degree college with 10 years experience in Services & Consulting
• Direct experience in hospital operations for at least a significant portion of their time with health systems
• Basic Knowledge of health IT systems, EMR, etc.

Desired Characteristics:

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems.
• Strong connection to the healthcare community with contacts to other healthcare professionals across the United States

Key Responsibilities:

Decision Making: Harness sophisticated judgment skills to navigate complex tasks or challenges in areas like operational management, product management, and consulting. Evaluate the quality and relevance of information, engage in critical questioning, and utilize a range of sources to arrive at well-informed decisions.

Required Qualifications:

• A Master’s degree from an accredited university with 6 years experience or Bachelors degree college with 8 years experience in Services & Consulting
• Direct experience in hospital operations for at least a significant portion of their time with health systems
• Basic Knowledge of health IT systems, EMR, etc.

Desired Characteristics

• Strong oral and written communication skills. Strong interpersonal and leadership skills. Demonstrated ability to analyze and resolve problems.
• Strong connection to the healthcare community with contacts to other healthcare professionals across the United States.

Roles and Responsibilities

• Executes against GE HealthCare's Central Quality & Regulatory Audit program. This includes scheduling, preparation, execution, reporting, and follow-up activities associated with Central Quality & Regulatory Internal Audits; identification and communication of high-risk issues; reporting compliance concerns and recommended improvements to business leadership; and ensuring audit strategy is executed to current industry practices and regulatory expectations.
• Supports GE HealthCare’s Health / Competent Authority audits. This includes preparation, back-room management, tracking of Lessons Learned, and driving follow-up activities.
• Supports GE HealthCare’s Quality Management System by defining, tracking, and maintaining metrics to promote early awareness and visibility of Quality & Regulatory issues. Regularly advises management in Central Quality.
• Requires specialized depth and/or breadth of expertise within a quality or regulatory discipline and ability to influence the development of strategy within own area, including participation in policy formulation.
• Requires ability to lead functional teams or projects with indirect resources and medium to high risk and/or complexity. Communicates difficult concepts and influences others' options on topics. May guide others to consider a different point of view.
• Impacts the team's ability to achieve service, quality, and timeliness of objectives. Work is subject to GEHC policy objectives.
• Uses high level of judgment to make decisions and handle complex tasks or problems. 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 construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.
• Develops self and others by promoting strong Quality & Regulatory practices, providing feedback, training, and mentorship, and collaborating with stakeholders to achieve desired results.

Required Qualifications

• Qualified Lead Auditor with active certification.
• Master’s Degree and a minimum of 7 years’ experience in the medical device industry; OR Bachelor's Degree and a minimum of 9 years’ experience in the medical device industry.
• Minimum of 5 years’ experience driving Global programs to resolve quality compliance issues (directly).
• Experience with Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Experience with auditing to ISO 17025, reviewing sterilization validations, protocols, SOPs, reports, and knowledge of ISO 10993 series, ISO 17664, ISO 11135, ISO 11137, data integrity, sample handling, and laboratory equipment including IQ, OQ, PQ, GLP, and GMP, as well as terminal sterilization methods.

Desired Characteristics

• Prior notified body or health authority experience a plus.
• ASQ Certification (CQE, CQA, etc.) and/or Lean Certification a plus (green belt, black belt). Software Quality Engineer (CSQE) strongly preferred.
• Design controls, design verification, and validation activities.
• Production and process controls.
• Class III US FDA PMA Device requirements.
• CAPA, complaints, and risk management.
• Understanding of product quality improvement using tools such as Six Sigma, DFR.
• Demonstrated ability to analyze and resolve problems.
• Exceptional conflict-resolution skills.
• Ability to interface with top organizational leadership and internal and external customers, responding in a professional manner.
• Demonstrated ability to lead programs / projects. Ability to prioritize and drive multiple programs.
• Ability to energize others by building a connection with the team through personal involvement and trust, providing feedback and coaching to develop others, and accountability of actions.
• Strong oral and written communication skills in English.
• Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others.
• Ability to travel domestically and internationally up to 40%.

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.