The Lead Engineer – Technical Regulations & Standards (India) will be a key member of the Product Compliance Engineering (PCE) organization, serving as the focal point for monitoring, interpreting, and communicating regulatory requirements and technical standards applicable to GE HealthCare products in India that fall outside traditional medical device regulatory frameworks.
This role will provide leadership and subject matter expertise for a broad range of horizontal regulations and standards, including but not limited to RoHS, chemical substance regulations, wireless requirements, environmental regulations, and other product compliance obligations. The individual will evaluate regulatory developments, assess business impacts, and drive alignment across the organization to ensure compliance while supporting GE HealthCare business objectives.
As part of the global PCE organization, this position will collaborate closely with product teams, compliance leaders, industry associations, and external stakeholders to ensure India-specific regulatory requirements are understood, interpreted consistently, and integrated into GE HealthCare’s global compliance strategy. The role may also involve engagement with regulatory authorities and standards bodies, under the direction of PCE leadership, to obtain clarity on regulatory expectations and compliance obligations.
The ideal candidate will possess strong technical and regulatory expertise related to India's product compliance landscape, coupled with the ability to translate complex regulatory requirements into practical business and engineering solutions. Success in this role requires effective cross-functional leadership, strong communication skills, and the ability to influence internal and external stakeholders in a dynamic regulatory environment.
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Roles & Responsibilities
Monitor, interpret, and communicate applicable environmental, wireless, and other technical regulations and standards mandated in India for GE HealthCare products. Drive awareness within the engineering community through the Compliance Change Notification (CCN) process and maintain notifications to reflect evolving regulatory requirements.
Partner with product development and engineering teams to ensure regulatory and standards requirements are clearly understood, consistently applied, and effectively integrated into product design and development activities.
Assess compliance strategies and recommend practical solutions that balance regulatory obligations with business and engineering needs, minimizing resource impact while ensuring full compliance.
Leverage technical expertise, regulatory knowledge, and analytical problem-solving skills to evaluate requirements, assess impacts, and make informed recommendations using input from both internal stakeholders and external sources.
Serve as a subject matter expert and mentor for compliance-related requirements, providing guidance, training, and knowledge sharing to build organizational capability and support consistent adherence to applicable regulations and standards.
Collaborate across global Product Compliance Engineering (PCE), engineering, sourcing, quality, and regulatory functions to drive alignment on interpretation, implementation, and compliance strategies for India-specific requirements.
Support regulatory engagement activities by helping prepare technical positions, responding to inquiries, and contributing to interactions with regulatory authorities, standards organizations, and industry associations as needed.
Required Qualifications
Advanced experience in engineering, product compliance, technical regulations, and standards, with a demonstrated ability to interpret and apply regulatory requirements in a product development environment.
Bachelor’s degree in Engineering, Science, or a related technical discipline from an accredited university, or equivalent combination of education and relevant experience.
Strong knowledge of India’s environmental, wireless, and product compliance regulations and standards, including the ability to assess regulatory impacts and translate requirements into actionable business and engineering guidance.
Solid understanding of product development, design control, and change management processes, with experience integrating regulatory requirements throughout the product lifecycle.
Excellent leadership, communication, and stakeholder management skills, with the ability to influence cross-functional teams, build alignment, and drive compliance outcomes across a global organization.
Strong analytical and problem-solving capabilities, with the ability to evaluate complex regulatory issues and develop practical, risk-based compliance solutions.
Demonstrated ability to collaborate effectively across engineering, regulatory, quality, sourcing, and business functions to achieve compliance and business objectives.
Desired Characteristics
Exceptional written and verbal communication skills, with the ability to clearly convey complex technical and regulatory requirements to diverse audiences across all levels of the organization.
Strong interpersonal, collaboration, and leadership skills, with a proven ability to influence stakeholders, build consensus, and drive action in a cross-functional environment.
Demonstrated analytical and problem-solving capabilities, including the ability to assess complex regulatory challenges, identify risks, and develop practical, business-oriented solutions.
Effective project management skills, with experience leading multiple initiatives simultaneously, managing priorities, and delivering results in a dynamic environment.
Experience working in regulated industries, with an understanding of compliance requirements across product development, manufacturing, and commercialization activities.
Experience operating within complex, global organizations, including multi-product portfolios, multi-tier supply chains, and geographically dispersed manufacturing environments.
Ability to navigate ambiguity and changing regulatory landscapes, while maintaining a proactive, customer-focused, and results-oriented approach.
Continuous improvement mindset, with a demonstrated ability to identify opportunities to streamline processes, improve efficiency, and enhance compliance effectiveness.
Education Qualification
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
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.
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.
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Relocation Assistance Provided: No
