Program Manager, Regulatory Affairs – Maternal Infant Care (MIC)
Company: GE HealthCare
Department: Healthcare Quality & Regulatory
Location: Bengaluru
Category: Quality & Regulatory Affairs
Career Level: Mid-Career
Job ID: R4038296
Relocation Assistance: No
Expected Salary
₹25–45 LPA CTC (typically ₹30–40 LPA for candidates with 6–10 years of Regulatory Affairs experience in medical devices)
Role Overview
The Program Manager, Regulatory Affairs will lead regulatory strategy and compliance activities for the Maternal Infant Care (MIC) business. The role involves managing global regulatory submissions, interacting with regulatory agencies worldwide, ensuring product compliance, and supporting product launches across international markets.
Key Responsibilities
Regulatory Strategy & Compliance
Define and execute global regulatory strategies for product launches.
Ensure compliance with international healthcare regulations.
Support pre-market approvals, registrations, and post-market regulatory requirements.
Global Regulatory Submissions
Prepare and submit regulatory filings to authorities such as:
FDA (510(k))
EU Regulatory Bodies
NMPA (China)
PMDA (Japan)
MFDS (South Korea)
CDSCO (India)
Coordinate with Engineering, Clinical, Scientific, and Quality teams.
Product Change Management
Evaluate product modifications and determine regulatory impact.
Assess requirements for revised approvals, registrations, or licenses.
Advertising & Promotional Review
Review marketing and promotional materials.
Ensure consistency with approved claims and regulatory requirements.
External Engagement
Participate in industry associations and standards organizations.
Influence evolving regulatory requirements and industry best practices.
Required Qualifications
Education
Bachelor's degree in:
Life Sciences
Engineering
Computer Science
Scientific Discipline
Equivalent experience
Experience
6+ years in regulated industries:
Medical Devices
Pharmaceuticals
Biologics
5+ years in Regulatory Affairs.
5+ years managing regulatory projects and agency interactions.
Experience preparing and authoring FDA 510(k) submissions.
Technical Skills
Knowledge of global regulatory frameworks.
Strong documentation and submission experience.
Proficiency in:
Microsoft Word
Excel
PowerPoint
Collaboration tools
Communication Skills
Strong written and verbal English communication.
Ability to present technical and regulatory information clearly.
Preferred Qualifications
Experience with:
Software as a Medical Device (SaMD)
Software in Medical Device (SiMD)
Cybersecurity regulations
Knowledge of Biocompatibility standards.
Experience with life-supporting and high-risk medical devices.
Master's degree or advanced scientific qualification.
Regulatory Affairs Certification (RAC) from RAPS.
Understanding of global healthcare market dynamics and regulatory trends.
Ideal Candidate Profile
Regulatory Affairs professional with 6–12 years of experience.
Strong FDA 510(k) submission expertise.
Experience working with global regulatory agencies.
Excellent cross-functional collaboration skills.
Medical device industry background preferred.
Ability to balance regulatory compliance with business objectives.
Career Progression
Regulatory Affairs Specialist → Senior Regulatory Affairs Manager → Program Manager → Director Regulatory Affairs → Global Regulatory Leader
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