Senior Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India (Flexible Work Arrangement)
Company: Medtronic
Employment Type: Full-Time
Job ID: R57795
About Medtronic
Medtronic is a global healthcare technology leader focused on advancing medical innovation and improving patient outcomes worldwide. Operating in more than 150 countries with a workforce of over 95,000 professionals, Medtronic develops cutting-edge healthcare technologies designed to alleviate pain, restore health, and extend life. The company fosters a culture of innovation, collaboration, and inclusion while addressing some of the most complex healthcare challenges globally.
Medtronic is currently seeking an experienced Senior Regulatory Affairs Specialist to support global regulatory strategies, regulatory submissions, and compliance activities for medical devices and healthcare products. This role plays a critical part in ensuring regulatory requirements are integrated into product development, commercialization, and lifecycle management.
Experience Required
Candidates should have a minimum of 7 years of experience in regulatory affairs within the medical device, pharmaceutical, or healthcare industry.
Key Responsibilities
Support design and development control activities by providing regulatory guidance, strategies, and compliance direction to cross-functional teams.
Establish and manage processes for entering and maintaining regulatory data within the Regulatory Information Management System (RIMS).
Serve as a subject matter expert for regulatory processes to ensure consistent interpretation and coordination of regulatory data attributes.
Prepare, review, and submit regulatory documentation for global product registrations, regulatory approvals, and compliance activities.
Develop and maintain regulatory files, documentation systems, and reporting processes for systematic retrieval of regulatory information.
Coordinate the preparation of documentation packages for international regulatory submissions, internal audits, and regulatory inspections.
Compile documentation required for license renewals, annual regulatory registrations, and regulatory updates.
Collaborate with business units and international regulatory teams to support marketing authorizations and regulatory approvals for assigned projects.
Recommend necessary changes to product labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance.
Monitor regulatory tracking systems and enhance document control processes to improve regulatory compliance and operational efficiency.
Communicate with regulatory agencies and notified bodies on administrative and routine regulatory matters.
Develop regulatory strategies for new or modified medical devices and products.
Monitor changes in global regulatory environments and assess their impact on ongoing regulatory activities and product registrations.
Document and maintain communication records with regulatory authorities, including written and verbal interactions.
Prepare internal regulatory documentation related to device modifications and regulatory updates.
Author and review regulatory procedures and update them as necessary to maintain compliance with evolving regulatory standards.
Review change control documentation and conduct regulatory impact assessments for both internal and external regulatory documentation.
Role Scope and Work Environment
This position requires collaboration with cross-functional teams including research and development, quality assurance, manufacturing, clinical affairs, and global regulatory teams. The role involves managing moderately complex regulatory projects while ensuring compliance with international regulatory requirements.
Required Qualifications
Bachelor’s degree in Medical, Mechanical, Electrical Engineering, Life Sciences, or another healthcare-related discipline.
Minimum of 7 years of experience in regulatory affairs within the medical device or pharmaceutical industry.
Strong knowledge of global regulatory submission processes and regulatory compliance frameworks.
Experience with regulatory documentation management and regulatory information management systems.
Ability to work independently while managing multiple regulatory projects and assignments.
Strong analytical, problem-solving, and regulatory strategy development skills.
Excellent communication and stakeholder management skills for interacting with internal teams and regulatory authorities.
Compensation and Benefits
Medtronic offers a competitive salary along with a comprehensive and flexible benefits package designed to support employees throughout their careers and personal lives.
Benefits may include performance incentives, participation in the Medtronic Incentive Plan (MIP), health and wellness programs, and career development opportunities.
Why Join Medtronic
Medtronic provides a purpose-driven work environment where innovation, collaboration, and healthcare advancement are at the core of the organization. Employees have the opportunity to contribute to life-changing healthcare technologies while building meaningful careers in regulatory affairs, clinical innovation, and global healthcare technology.
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