Location: Nanakramguda, Hyderabad, India
Company: Medtronic
Job Type: Full-Time
Job ID: R62703
Experience Required: 4–7 Years (Not suitable for freshers)
About the Company
Medtronic is a global leader in healthcare technology, dedicated to transforming patient care through innovation, accessibility, and equity. With a workforce of over 95,000 professionals worldwide, the organization focuses on solving some of the most complex healthcare challenges by integrating engineering excellence with clinical expertise.
Job Overview
The Regulatory Affairs Specialist will be responsible for supporting global regulatory submissions, compliance strategies, and product lifecycle management for medical devices and pharmaceutical products. This role requires strong expertise in regulatory frameworks across India, US, and EU markets, along with the ability to collaborate across cross-functional teams in a dynamic environment.
Key Responsibilities
Prepare, review, and submit premarket regulatory documents for global product registrations
Support marketing authorizations by collaborating with international regulatory teams
Review pre-clinical and clinical documentation for regulatory submissions
Develop and execute regulatory strategies for new and modified products
Monitor evolving regulatory landscapes and assess their impact on ongoing projects
Maintain communication with global health authorities and regulatory bodies
Compile and manage submission dossiers, license renewals, and annual registrations
Participate in regulatory inspections, notified body audits, and compliance reviews
Author and update regulatory SOPs and internal procedures
Assess change control documentation for regulatory impact and compliance
Maintain regulatory databases, documentation systems, and reporting frameworks
Ensure promotional materials and labeling meet regulatory standards
Support compliance for raw materials, prototypes, and product approvals
Required Qualifications
Bachelor’s degree in Life Sciences, Pharmacy, Medical, Mechanical, Electrical, or related healthcare fields
4–7 years of experience in Regulatory Affairs within medical devices or pharmaceutical industry
Strong knowledge of regulatory guidelines including India CDSCO, US FDA, and EU MDR
Ability to interpret and apply international regulatory requirements
Excellent written and verbal communication skills
Strong organizational, analytical, and multitasking abilities
Proficiency in English (reading, writing, and speaking)
Detail-oriented with the ability to work under pressure and meet deadlines
Preferred Skills (Nice to Have)
Exposure to global regulatory submissions and multi-region approvals
Experience working with cross-functional and global teams
Project management skills with strong adherence to timelines
Problem-solving mindset with proactive decision-making abilities
Strong interpersonal, negotiation, and stakeholder management skills
RAPS Regulatory Affairs Certification (RAC) is an added advantage
Work Environment & Expectations
Ability to manage multiple projects in a fast-paced regulatory environment
Strong collaboration across departments including R&D, Quality, Clinical, and Manufacturing
High level of professionalism, adaptability, and continuous learning mindset
Compensation & Benefits
Medtronic offers a competitive compensation structure along with a comprehensive benefits package designed to support employees across all career stages.
Performance-based incentives including Medtronic Incentive Plan (MIP)
Health, wellness, and financial benefits
Career development and internal growth opportunities
Inclusive and innovation-driven workplace culture
Important Note for Applicants
This is a mid-level Regulatory Affairs role requiring prior industry experience. Freshers are advised to apply for entry-level roles such as Regulatory Affairs Associate, Pharmacovigilance Associate, or Clinical Research Coordinator to build foundational expertise before transitioning into specialist roles.
How to Apply
Interested candidates can apply through the official careers page of Medtronic or explore more verified global opportunities on ThePharmaDaily.com, your trusted platform for pharmaceutical and clinical research careers.
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