Are you passionate about regulatory affairs and global compliance in the medical device industry? GE HealthCare, a leader in healthcare innovation, is hiring a Lead Specialist, Regulatory Affairs in Bengaluru, Karnataka. This role offers a unique opportunity to drive global market access for Imaging Accessories & Supplies (A&S) products, ensuring compliance with international regulations. Join a dynamic team and contribute to life-changing healthcare solutions with a company renowned for its commitment to inclusion, diversity, and innovation.
Roles and Responsibilities
As a Lead Specialist in Regulatory Affairs, you will play a pivotal role in maintaining global compliance for GE HealthCare’s A&S products. Key responsibilities include:
- Global Submission Support: Collaborate with regulatory teams and product managers to compile documentation for global market submissions.
- Supplier Documentation Management: Request, maintain, and organize supplier documentation (e.g., credentialing documents, international certificates, product labels) in designated databases.
- Supplier Relationship Building: Foster strong relationships with third-party suppliers to ensure timely delivery of required documentation for global distribution.
- Regulatory Strategy Maintenance: Under the guidance of A&S Product RA, develop and maintain regulatory strategies to support supplier operations and market access.
- Global Regulatory Updates: Monitor and update global regulatory requirements to facilitate continuous market access and assess product changes for new or revised licenses.
- Compliance Assurance: Ensure third-party suppliers meet regulatory requirements and provide updated country license information per business timelines.
Required Qualifications
To excel in this role, candidates must meet the following qualifications:
- Education: Bachelor’s degree in a Scientific, Engineering, Computer Science, or core Life Science discipline, or equivalent training and experience.
- Experience: Minimum of 8+ years in regulated fields (e.g., medical devices, pharmaceuticals, biologics) and 6+ years in international regulatory affairs or supplier quality operations.
- Communication Skills: Excellent verbal and written English communication skills, with the ability to tailor messages to diverse stakeholders.
- Research and Analytical Skills: Proficient in using research tools to synthesize complex information for submissions and decision-making.
- Technical Proficiency: Strong experience with MS Office (Word, Excel, PowerPoint), Adobe Acrobat, and project management tools.
- Project Management: Proven skills in managing projects and collaborating effectively with cross-functional teams.
Desired Characteristics
While not mandatory, the following traits will set you apart:
- Experience in supporting manufacturing operations or supply quality engineering.
- Familiarity with high-risk, life-supporting, or life-sustaining medical devices.
- Advanced degree in scientific, technology, or regulatory affairs disciplines.
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
- A proactive, learning-oriented mindset with flexibility to adapt to evolving regulations.
Benefits
GE HealthCare offers a comprehensive rewards package designed to support your career and well-being:
- Competitive Salary: Annual salary range of INR 15,00,000–20,00,000, commensurate with experience.
- Global Exposure: Work on international projects with a leading healthcare organization.
- Inclusive Culture: Join a workplace that values diversity, equity, and inclusion.
- Career Growth: Access opportunities for professional development in a collaborative environment.
- Comprehensive Benefits: Enjoy health, wellness, and work-life balance programs tailored to your needs.
How to Apply
Ready to make a difference in global healthcare? Submit your application through the GE HealthCare careers portal at Pharmabharat.com. Include your resume, cover letter, and relevant certifications. Applications are reviewed on a rolling basis, with a deadline of September 24, 2025. For inquiries, contact the GE HealthCare HR team via the portal.
FAQs
Q: What is the role of a Lead Specialist in Regulatory Affairs at GE HealthCare?
A: The Lead Specialist ensures global compliance for A&S products by managing supplier documentation, supporting market access, and maintaining regulatory strategies.
Q: Is relocation assistance provided for this position?
A: No, relocation assistance is not provided for this role.
