Job Opportunity: Regulatory Affairs Specialist at Medtronic

Job Summary

Medtronic, a global leader in healthcare technology, is seeking a dedicated and experienced Regulatory Affairs Specialist to join our team in Nanakramguda, Hyderabad. In this role, you will be instrumental in driving our mission to alleviate pain, restore health, and extend life by ensuring our medical technologies meet the highest global regulatory standards. This is an ideal position for a professional with 4–7 years of industry experience looking to advance their career in regulatory strategy, compliance, and international product submissions within a collaborative, innovative, and global environment.

Job Overview

• Job Title: Regulatory Affairs Specialist
• Company: Medtronic
• Location: Nanakramguda, Hyderabad, India
• Employment Type: Full-Time
• Work Mode: Flexible Work Arrangement
• Experience Required: 4–7 Years
• Industry: Pharmaceutical / Medical Devices

Responsibilities

As a Regulatory Affairs Specialist, you will act as a key liaison between Medtronic and global health authorities. Your daily responsibilities will include:

• Regulatory Submissions: Prepare, review, and manage the submission of regulatory documents to ensure successful product registrations across global markets.
• Strategy Development: Partner with product development teams to create robust regulatory strategies for both new and modified medical devices.
• Cross-Functional Collaboration: Work closely with international regulatory teams, clinical departments, and pre-clinical teams to ensure submission readiness and data integrity.
• Regulatory Intelligence: Monitor and analyze changes in global regulatory landscapes—specifically concerning the US FDA, EU regulations, and the Indian regulatory framework—to ensure ongoing compliance.
• Quality & Compliance: Support internal audits, regulatory inspections, and external assessments. Review product labeling and promotional materials for regulatory alignment.
• Documentation Management: Maintain rigorous regulatory documentation systems, ensuring accurate records and adherence to company policies and health authority standards.

Requirements

We are looking for a detail-oriented professional who thrives in a fast-paced environment. Candidates should possess:

• Education: Bachelor’s degree in Life Sciences, Medicine, Mechanical Engineering, Electrical Engineering, or a closely related field.
• Experience: 4–7 years of direct experience in regulatory affairs within the pharmaceutical or medical device industry.
• Technical Knowledge: Comprehensive understanding of global regulatory frameworks, including US FDA, EU MDR, and Indian regulatory requirements.
• Communication: Exceptional written and verbal communication skills in English, with the ability to convey complex information clearly.
• Soft Skills: Strong analytical capabilities, excellent organizational skills, and a proven ability to manage multiple high-priority projects simultaneously.
• Collaboration: A proactive team player with the ability to work effectively in a diverse, cross-functional, and international environment.

Preferred Qualifications:

• Proven track record with global regulatory submissions.
• Regulatory Affairs Certification (RAC) from RAPS.
• Strong project management and complex problem-solving skills.

Benefits

Medtronic is committed to the professional and personal well-being of its employees. We offer a comprehensive benefits package designed to support you at every stage of your career:

• Competitive Compensation: An attractive salary package (estimated between ₹8,00,000 – ₹15,00,000 per annum).
• Incentives: Participation in the Medtronic Incentive Plan (MIP).
• Health & Wellness: Robust health and wellness programs to support you and your family.
• Professional Development: Significant opportunities for career growth, global exposure, and continuous learning.
• Work Environment: An inclusive, supportive, and innovative culture that values diverse perspectives.

How to Apply

If you are passionate about shaping the future of healthcare and meet the qualifications listed above, we invite you to apply. Please visit the official Medtronic careers portal to submit your application and view further details regarding the role.

Apply for the Regulatory Affairs Specialist Position Here