Job Summary:
Medtronic, a global leader in healthcare technology, is hiring a Senior Regulatory Affairs Specialist for its Hyderabad location. This hybrid role offers a unique opportunity to develop and implement compliant regulatory processes in the medical device industry. Be part of a company committed to transforming healthcare and making a real impact on patients' lives worldwide.
Key Responsibilities:
Develop and implement regulatory processes within the Regulatory Affairs organization.
Establish new processes for Regulatory Information Management Systems (RIMS).
Act as a subject matter expert ensuring consistency in regulatory data interpretation.
Stay updated on global regulatory procedures and changes.
Provide necessary regulatory documentation for global tenders and submissions.
Maintain and enhance regulatory filing, documentation, and tracking systems.
Prepare and support premarket documents for global regulatory submissions.
Coordinate with global regulatory teams to support market authorizations.
Review and recommend changes for product labeling, marketing, manufacturing, and clinical protocols.
Handle direct communication with regulatory agencies on specific matters.
Develop regulatory strategies for new or modified products.
Monitor and assess the impact of evolving regulatory environments.
Review change control documents for regulatory impact assessments.
Required Skills & Qualifications:
Bachelor's degree in Medical, Mechanical, Electrical, Life Sciences, or related healthcare fields.
Minimum 7 years of experience in Regulatory Affairs within the medical device or pharmaceutical industry.
Proficiency in handling regulatory data systems and global submission processes.
Strong verbal and written communication skills.
Ability to manage complex projects independently.
Problem-solving mindset with attention to detail and organizational skills.
Experience working in cross-functional teams.
Knowledge of US and global regulatory requirements preferred.
RAPS Regulatory Affairs Certification (RAC) is an advantage.
Perks & Benefits:
Competitive salary package.
Flexible benefits tailored to various career and life stages.
Learning & development programs for career advancement.
Work with a global leader in healthcare technology.
Hybrid work model offering flexibility and work-life balance.
About Medtronic:
Medtronic is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life. With over 95,000 employees worldwide, Medtronic drives innovation in medical devices and therapies. Its diverse and inclusive workforce contributes to cutting-edge healthcare solutions that shape the future of medicine.
Work Mode:
Hybrid (Nanakramguda, Hyderabad, India)
Call to Action:
Ready to contribute to the future of healthcare? Apply now to join Medtronic’s world-class Regulatory Affairs team and advance your career in the medical device industry.
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