Senior Regulatory Affairs Specialist – Hybrid – Hyderabad (Nanakramguda)
Location: Nanakramguda, Hyderabad, India
Job Type: Full-Time | Hybrid
Requisition ID: R29633
Posted: 21 Days Ago
About the Role:
Medtronic is seeking a Senior Regulatory Affairs Specialist to lead the development and implementation of compliant regulatory processes. In this role, you'll coordinate global regulatory submissions, support international registrations, and play a key role in enhancing systems, documentation, and regulatory strategy across multiple product lines.
This is a critical opportunity for professionals experienced in navigating medical device or pharmaceutical regulatory pathways to contribute meaningfully to global healthcare access.
Key Responsibilities:
Develop and maintain Regulatory Information Management Systems and support accurate data entry processes.
Serve as Subject Matter Expert (SME) to ensure consistent interpretation and coordination of regulatory data.
Stay updated with evolving global regulatory procedures and recommend improvements.
Support tender documentation and regulatory data submissions across business units.
Collaborate with internal regulatory teams to coordinate and submit premarket applications and international registrations.
Prepare document packages and respond to audits and regulatory inspections.
Ensure timely license renewals, annual registrations, and monitor compliance with labelling, clinical, and manufacturing standards.
Review change control documents, assess regulatory impacts, and recommend strategic improvements.
Draft, review, and update regulatory SOPs, compliance documents, and technical files.
Lead or support global regulatory communication, including liaising with health authorities and Notified Bodies.
Minimum Qualifications:
Bachelor’s degree in Life Sciences, Medical, Mechanical, or Electrical disciplines.
7+ years of experience in regulatory affairs within the medical device and/or pharmaceutical industry.
Ability to work independently with general supervision, handling complex global projects.
Strong communication skills for collaborating across teams and with regulatory authorities.
Proven experience in managing project timelines, compliance requirements, and cross-functional coordination.
Preferred Qualifications:
Knowledge of US FDA and international regulatory frameworks.
Experience working with cross-functional teams in fast-paced environments.
Project management experience with demonstrated adherence to schedules.
RAPS Regulatory Affairs Certification (RAC).
Ability to handle regulatory challenges under pressure with professionalism and clarity.
Experience reviewing technical documentation, change controls, and regulatory strategies for evolving product lines.
Work Environment:
Hybrid work model with flexibility to operate from Medtronic’s Hyderabad office.
Occasional interaction with global teams across time zones.
Benefits & Compensation:
Competitive salary and flexible benefits package.
Incentives aligned with performance milestones and career development opportunities.
Inclusive work environment emphasizing innovation, growth, and global collaboration.
Estimated Salary: ₹18 – ₹28 LPA (based on experience and market benchmarks)
Gujarat :
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