Lead Specialist - Regulatory Affairs
Company: GE Healthcare
Location: Bengaluru, Karnataka, India
Job Type: Full Time
Experience Required: Minimum 7 years in Regulatory Affairs / Quality in the healthcare or medical device industry
Job ID: R4035754
Role Overview
GE Healthcare is seeking a Lead Specialist in Regulatory Affairs to provide regulatory strategy and guidance for product launch, premarket submissions, and postmarket compliance. This role involves working closely with global healthcare regulatory bodies and cross-functional teams to ensure all regulatory requirements are met efficiently and accurately. The position combines technical expertise, strategic planning, and strong collaboration skills to impact product compliance and quality standards.
Key Responsibilities
Develop and implement regulatory strategies for new product launches, premarket registrations/submissions, and postmarket compliance.
Maintain knowledge of global regulatory frameworks and ensure adherence to applicable healthcare regulations.
Serve as a subject matter expert in regulatory affairs, providing guidance on compliance, documentation, and regulatory risk mitigation.
Collaborate with cross-functional teams including product development, quality, and operations to support regulatory submissions.
Provide guidance and mentorship to junior team members, translating complex regulatory requirements into actionable steps.
Evaluate regulatory impact of changes in product design, labeling, or manufacturing processes.
Analyze and solve regulatory challenges using technical expertise and sound judgment.
Participate in audits, inspections, and regulatory reviews as required.
Required Qualifications and Experience
Bachelor’s degree from an accredited university or equivalent combination of education and relevant experience.
Minimum of 7 years of experience in Quality Assurance or Regulatory Affairs within the healthcare or medical device industry.
Demonstrated knowledge of medical device regulations and compliance requirements.
Proven experience in product submissions, regulatory strategy, and postmarket compliance.
Strong analytical, problem-solving, and decision-making skills.
Excellent interpersonal and communication skills for effective collaboration across teams.
Preferred Skills
Bachelor’s degree in Engineering, Biomedical Sciences, or a related discipline.
Minimum 3 years of experience in medical device manufacturing, particularly in quality control or regulatory functions.
Familiarity with lean six sigma principles, project management methodologies, and regulatory documentation processes.
Proficiency in Microsoft Office Suite (Excel, PowerPoint).
Willingness to travel domestically and internationally (~10%).
Inclusion and Diversity
GE Healthcare is an equal opportunity employer. Employment decisions are made without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, disability, or other legally protected characteristics. Employees are expected to act with integrity, transparency, and ownership while contributing to a collaborative and high-performing culture.
Why GE Healthcare
Joining GE Healthcare provides exposure to global regulatory affairs operations, professional development, and opportunities to impact healthcare quality worldwide. The role allows for strategic influence, cross-functional collaboration, and contribution to high-impact regulatory initiatives.
Additional Information
Relocation Assistance: Not Provided
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