Lead Specialist Regulatory Affairs

Lead Specialist Regulatory Affairs

Job Description Summary

The Regulatory Affairs supports regulatory activities for assigned products and markets throughout the product lifecycle. This level role is designed for an early regulatory career professional who will learn and apply country- and region-specific regulations, standards, internal procedures, and product knowledge to prepare high-quality regulatory documentation, support submissions and compliance deliverables, and contribute to timely market access and continued product compliance. Provides regulatory support for Maternal Infant Care regulatory programs across the product lifecycle, including global registration planning, submissions, notified body and quality system audits, program implementation, and pre- and post-market compliance.

The role works collaboratively across a matrixed organization and provides an opportunity to build practical regulatory expertise while contributing to go-to-market strategies and solutions for low- to moderate-complexity regulatory matters under appropriate guidance and supervision. Works across a cross-functional matrix and communicates regulatory strategy, risks, decisions, and program status to leadership and other stakeholders.

GE Healthcare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. 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

Key Responsibilities

• Learn and apply applicable country- and region-specific regulations, standards, guidance, and internal regulatory procedures.  Understand and apply regulatory requirements and their impact on submissions and pre- and post-market compliance.
• Provide global RA support for registration planning, submissions, notified body and quality system audits, and program implementation; support compliance of premarket submissions/registrations and post-market activities while working with healthcare regulatory bodies globally.
• Contribute to writing and editing technical documents and research, analyze, integrate, and organize information from diverse sources for regulatory submissions.
• Support development of practical go-to-market strategies by identifying regulatory requirements, constraints, dependencies, and timelines, and escalating concerns early.
• Monitor changes to applicable regulations and standards and assist in assessing potential impact on assigned products, markets, documentation, and regulatory commitments. 
• Develop and maintain working technical knowledge of assigned products, including intended use, design and performance characteristics, manufacturing context, and applicable operating environments; build awareness of adjacent product lines. 
• Research relevant regulatory and technical information, help evaluate options, and contribute to practical solutions for low- to moderate-complexity matters. 
• Follow established procedures and exercise sound judgment; identify questions, risks, or trade-offs and seek management or subject-matter-expert input when appropriate. 
• Organize individual work, manage multiple priorities, and deliver assigned work on agreed timelines with limited direct oversight as experience develops
• Communicate regulatory information clearly and concisely through written, verbal, virtual, and in-person channels, adapting the approach to the audience and situation. 
• Collaborate respectfully with Regulatory Affairs colleagues and cross-functional partners, including Quality Assurance, Engineering/Design, Manufacturing, Clinical, Marketing, and business stakeholders. 
• Maintain integrity, confidentiality, data accuracy, and high quality standards in all interactions, records, and deliverables.

Qualifications

• Bachelor’s degree from an accredited university; a degree in science, engineering, health sciences, legal studies, regulatory affairs, quality, or a related discipline is preferred. 
• 6-8 years of relevant professional experience. Relevant experience may include Regulatory Affairs, Quality Assurance, product design or engineering, manufacturing, clinical, laboratory, compliance, or another role within a regulated industry. 
• Minimum of 3+ years of experience working in a regulated field. Regulatory Affairs experience preferred.
• Strong written and oral communication skills in English.

Characteristics

• Ability to understand technical documentation and execute associated procedures.
• Strong communication, project-management, and organizational skills.
• Ability to research relevant information, analyze issues, explain findings clearly, and recognize when additional guidance is needed. 
• Clear and timely communication, active listening, and concise professional writing.
• Collaborative approach and ability to work effectively across functions in a matrix organization.  Team-oriented and responsive to customer needs.
• Integrity, transparency, respect, adaptability, self-motivation, sound judgment, and calmness under pressure.  Ability to work independently in a fast-paced environment and adapt to change; attention to detail and results orientation.
• Empathy, humility, kindness, and professionalism in working relationships.

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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Additional Information

Experience Level

Senior Level