Senior Regulatory Affairs Specialist – Surgical OU
Location: Nanakramguda, Hyderabad, India (Hybrid)
Job Type: Full-Time, Permanent
About Medtronic
Medtronic is a global leader in healthcare technology, committed to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, Medtronic combines innovation, engineering, and clinical expertise to deliver cutting-edge solutions in medical devices, surgical robotics, and digital health.
Joining Medtronic means contributing to transformative healthcare solutions, advancing surgical innovations, and improving patient outcomes globally.
Role Overview
The Senior Regulatory Affairs Specialist will be responsible for developing, implementing, and maintaining compliant regulatory processes within the Surgical Operating Unit (OU). This role ensures accurate regulatory data management, compliance with global standards, and process optimization through digital tools and AI applications.
This position requires close collaboration with cross-functional teams, global regulatory stakeholders, and alignment with Medtronic’s mission of innovative healthcare delivery.
Key Responsibilities
Regulatory Operations & Data Management
Own and manage multiple regulatory processes, including Regulatory Information Management System (RIMS), Global Item Create (GIC), and tender requests.
Act as Data Steward for RIMS, GIC, and tenders, ensuring accuracy and compliance.
Liaise with OU Regulatory teams to maintain correct application of regulatory processes and data attributes.
Report and analyze regulatory metrics and data.
Convert technical documents into Global Submission Summary Documentation (GSSD).
Create e-BOM structures in CAP Agile for submission documents.
Streamline processes leveraging Artificial Intelligence tools.
Compliance & Quality
Monitor compliance with multiple Quality Management Systems.
Stay current with regulatory procedures and updates, ensuring adherence to global standards.
Contribute to project milestones, ensuring deliverables meet internal and external regulatory requirements.
Collaboration & Project Support
Communicate and collaborate effectively with internal teams, cross-functional stakeholders, and global regulatory personnel.
Support project management, including coordination across time zones (US EST alignment required).
Identify process improvements and recommend enhancements to regulatory systems and workflows.
Qualifications & Experience
Required:
Bachelor’s degree in Medical, Mechanical, Life Sciences, or healthcare-related field.
Minimum 7 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
Proven ability to work independently on complex projects, ensuring compliance and timely delivery.
Strong communication skills, both verbal and written, for internal and external stakeholders.
Flexible to work in US EST time zone as required.
Preferred / Nice to Have:
Experience in US and global regulatory frameworks.
Familiarity with cross-functional team collaboration and project management.
RAPS Regulatory Affairs Certification (RAC).
Ability to manage multiple projects efficiently in a dynamic, high-pressure environment.
Strong interpersonal, negotiation, and influencing skills.
Why Join Medtronic
Be part of a global healthcare leader driving innovation in surgical and robotic solutions.
Contribute to projects that impact patient care worldwide.
Access career development programs designed to accelerate growth and expertise.
Flexible hybrid working model with opportunities to collaborate globally.
Competitive salary, benefits, and incentive programs tailored to employee well-being and career progression.
Equal Opportunity Employer:
Medtronic is committed to diversity, equity, and inclusion, providing equal employment opportunities regardless of race, gender, disability, age, or other legally protected characteristics.
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