Instagram
youtube
Facebook

Regulatory Affairs Specialist

4-7 years
Not Disclosed
10 Nov. 18, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Regulatory Affairs Specialist – Hybrid (Hyderabad, India)

Location: Nanakramguda, Hyderabad, India (Hybrid)

Experience Required: 4–7 years in regulatory affairs within the medical device or pharmaceutical industry

Education: Bachelor’s degree in Medical, Mechanical, Life Sciences, or Healthcare-related field

About the Role:
Medtronic is seeking a Regulatory Affairs Specialist to join the Surgical Operating Unit (OU) Regulatory team. In this role, you will develop and implement compliant regulatory processes, manage documentation for global submissions, and streamline operations using advanced tools, including AI-based systems. This position requires collaboration with cross-functional teams and global stakeholders to ensure regulatory compliance while supporting innovative surgical and robotic solutions.

Key Responsibilities:

  • Liaise with OU Regulatory teams to ensure accurate application of processes and assignment of data attributes.

  • Convert technical documents into Global Submission Summary Documentation (GSSD).

  • Create and maintain e-BOM structures in CAP Agile for GSSD.

  • Monitor regulatory compliance across multiple Quality Management Systems.

  • Stay current with evolving regulatory procedures, guidelines, and global standards.

  • Recommend and implement process improvements to enhance efficiency and compliance.

  • Communicate regularly with internal stakeholders to provide updates, address issues, and support decision-making.

  • Support project management, ensuring timely completion of regulatory milestones.

  • Participate in cross-functional collaboration and team meetings.

Qualifications & Skills:

  • 4–7 years of experience in regulatory affairs for medical devices or pharmaceuticals.

  • Strong understanding of US and global regulatory frameworks.

  • Proven experience with cross-functional team collaboration.

  • Excellent verbal and written communication skills.

  • Highly organized, detail-oriented, and capable of managing multiple projects under tight deadlines.

  • Proficiency in project management and regulatory documentation processes.

  • Ability to work independently and adapt to flexible hours, including US EST time zone requirements.

  • RAPS Regulatory Affairs Certification (RAC) is a plus.

  • Strategic mindset with problem-solving and negotiation skills.

Why Join Medtronic:

  • Be part of a global leader in healthcare technology with 95,000+ employees worldwide.

  • Work on innovative surgical and robotic solutions improving patient outcomes.

  • Access to career growth, professional development programs, and leadership training.

  • Competitive salary, flexible benefits, and short-term incentive plans (Medtronic Incentive Plan).

  • Inclusive work environment promoting diversity, equity, and collaboration.

About Medtronic:
Medtronic is a global healthcare technology company committed to alleviating pain, restoring health, and extending life. With operations spanning 150+ countries, we lead in innovation, creating solutions that address complex health challenges. Our mission drives a culture of exploration, collaboration, and purpose, offering employees opportunities to contribute meaningfully while advancing their careers.

How to Apply:
Qualified candidates can submit their resume for consideration to join Medtronic’s Regulatory Affairs team in Hyderabad.

#Hiring #RegulatoryAffairs #MedicalDevices #PharmaJobs #Medtronic #HyderabadJobs