Post Market CoE Regulatory Affairs Lead Specialist
Company: GE Healthcare
Location: Bengaluru, Karnataka, India
Job Type: Full Time
Experience Required: 7+ years in Quality & Regulatory Affairs in the medical device or healthcare industry
Job ID: R4033759
Role Overview
GE Healthcare is seeking a Post Market CoE Regulatory Affairs Lead Specialist to provide strategic guidance on post-market compliance for medical devices. This role ensures alignment with global healthcare regulatory requirements, manages post-market activities, and liaises with regulatory authorities worldwide. The position demands a deep understanding of regulatory standards, risk management, and post-market surveillance processes to ensure product safety, compliance, and lifecycle management.
Key Responsibilities
Lead regulatory strategy and provide direction for post-market compliance, collaborating closely with global healthcare regulatory bodies.
Monitor and evaluate post-market requirements, ensuring alignment with local and international regulations.
Execute functional policy and regulatory strategies within the post-market discipline, applying professional judgment to resolve complex issues.
Provide guidance to team members on regulatory processes and share expertise to support operational excellence.
Collaborate across multifunctional teams to integrate post-market compliance activities with product quality, engineering, and clinical teams.
Analyze technical and regulatory data to develop solutions for compliance gaps, process improvements, and risk mitigation.
Maintain documentation and reporting of post-market compliance activities in accordance with regulatory requirements.
Required Qualifications and Experience
Minimum 7 years of experience in Quality & Regulatory Affairs, preferably within medical device manufacturing or healthcare.
Bachelor’s degree from an accredited university or college; professional experience may substitute for formal education.
Strong knowledge of medical device regulations, post-market compliance, and regulatory frameworks.
Experience in root cause analysis, corrective and preventive actions (CAPA), and post-market surveillance.
Preferred Skills
Bachelor’s degree in Engineering, Biomedical Sciences, or related discipline.
Proficiency in project management methodologies, Lean Six Sigma principles, and quality improvement processes.
Excellent problem-solving, analytical, and communication skills.
Ability to work effectively in cross-functional and international teams.
Proficiency in Microsoft Office Suite (Excel, PowerPoint, Word).
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, age, disability, or other protected characteristics. Employees are expected to uphold integrity, transparency, and ownership while fostering a collaborative and high-performing work culture.
Additional Information
Relocation Assistance: Not Provided
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