Regulatory Affairs Specialist
Location: Nanakramguda, Hyderabad, India (Flexible Work Arrangement)
Company: Medtronic
Employment Type: Full-Time
Job ID: R58481
About Medtronic
Medtronic is a global leader in healthcare technology committed to improving patient outcomes through innovative medical solutions. With operations in more than 150 countries and a workforce of over 95,000 professionals, the company focuses on advancing healthcare technologies that alleviate pain, restore health, and extend life. Medtronic fosters a culture of innovation, collaboration, and inclusion while addressing some of the world’s most complex healthcare challenges.
Medtronic is currently seeking a Regulatory Affairs Specialist to support regulatory strategy, compliance, and submission activities related to medical devices and clinical research. This role plays a key part in ensuring regulatory compliance throughout the product lifecycle, including design, development, and commercialization.
Experience Required
Candidates should have 4 to 7 years of relevant experience in regulatory affairs, regulatory compliance, or regulatory submissions within the medical device, pharmaceutical, or healthcare technology industry.
Key Responsibilities
Support design and development control activities by providing regulatory guidance, direction, and strategies in collaboration with cross-functional teams.
Coordinate and prepare documentation packages required for regulatory submissions, internal audits, and regulatory inspections.
Compile and manage all materials required for regulatory submissions, product license renewals, and annual regulatory registrations.
Recommend necessary changes to product labeling, manufacturing processes, marketing materials, and clinical protocols to ensure regulatory compliance.
Monitor and maintain regulatory tracking and documentation control systems to ensure proper record management and submission timelines.
Stay updated with evolving global regulatory requirements, procedures, and industry standards.
Interact with regulatory authorities when required to address defined regulatory matters.
Contribute to the development of regulatory strategies that support timely approvals for clinical trial applications and product registrations.
Collaborate with internal teams including research and development, quality assurance, manufacturing, and clinical teams to ensure regulatory compliance throughout product development.
Role Scope and Work Environment
This role involves working closely with multidisciplinary teams to ensure that regulatory requirements are integrated into product development and commercialization processes. The position requires strong documentation management skills, regulatory knowledge, and the ability to coordinate submission activities across multiple departments.
Required Qualifications
Bachelor’s degree in Engineering (B.Tech) or a related technical discipline.
4 to 7 years of professional experience in regulatory affairs, regulatory compliance, or regulatory submission management.
Understanding of regulatory guidelines and submission requirements for medical devices or healthcare products.
Experience with regulatory documentation preparation, submission processes, and regulatory audits.
Strong analytical and problem-solving skills.
Ability to manage documentation processes and regulatory tracking systems.
Excellent communication and collaboration skills for working with cross-functional teams.
Compensation and Benefits
Medtronic offers a competitive salary along with a flexible benefits package designed to support employees throughout their career and personal development.
Benefits may include competitive compensation, performance incentives, participation in the Medtronic Incentive Plan (MIP), health and wellness programs, and professional development opportunities.
Why Join Medtronic
Medtronic provides a dynamic work environment where innovation, collaboration, and purpose-driven work are encouraged. Employees have the opportunity to contribute to advanced healthcare technologies that address global medical challenges. Joining Medtronic enables professionals to build impactful careers while helping improve and extend the lives of patients worldwide.
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