Regulatory Affairs Specialist Ii

Medtronic

4-7 years

Not Disclosed

Hyderabad

10 Jan. 16, 2025

Job Description

Job Type: Education: B.Sc./M.Sc./B.Pharm/M.Pharm/B.E./BCS 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

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Regulatory Affairs Specialist II

Remote Type: Hybrid
Locations: Nanakramguda, Hyderabad, India
Time Type: Full-Time
Posted On: 12 Days Ago
Job Requisition ID: R14999

About Medtronic

At Medtronic, we pioneer life-long careers of innovation, breaking down barriers to healthcare equity in a compassionate, connected world. United by our mission to alleviate pain, restore health, and extend life, our team of over 90,000 passionate professionals engineers extraordinary solutions to humanity’s toughest health challenges.

A Day in the Life

In this role, you will collaborate with Design QA, R&D, Sustaining Engineering, Clinical Affairs, Marketing, and Operations. As the local representative for Regulatory Affairs, you will ensure compliance with Indian and global regulations. You will support research and development activities, design controls, and provide strategic direction while working cross-functionally with all departments.

Key Responsibilities

Prepare, review, file, and support premarket documents for global registrations.
Collaborate with business units and international regulatory affairs teams to secure marketing authorizations.
Represent Regulatory Affairs in product development projects from concept to commercialization.
Review clinical protocols and associated reports for regulatory submissions.
Develop and execute regulatory strategies for new or modified products.
Monitor and assess regulatory environment changes for potential impacts.
Communicate with regulatory agencies and maintain documentation of communications.
Review and assess the regulatory impact of device modifications.
Participate in health agency inspections and notified body audits.
Author and update regulatory procedures as necessary.
Ensure compliance with regulations for MEIC-developed product materials and prototypes.

Qualifications

Education:

Bachelor’s degree in Medical, Mechanical, Electrical Life Science, or other healthcare-related majors.

Experience:

4–7 years in a Regulatory Affairs role within the medical device or pharmaceutical industry.
Familiarity with India, US FDA, and EU regulations and the ability to interpret international requirements.

Skills:

Strong written, organizational, and communication abilities.
Attention to detail and the capacity to manage multiple tasks under pressure.
Proficient in English (reading, writing, speaking).
Flexible, team-oriented, with a strong learning attitude.

Physical Job Requirements

The above responsibilities and skills describe the general nature of this role and are not an exhaustive list.

Benefits & Compensation

Medtronic provides a competitive salary, flexible benefits, and comprehensive compensation plans designed to support you at every career and life stage.

Learn More About Us

Medtronic’s mission is to engineer the extraordinary. From R&D labs to conference rooms, our diverse and talented team works tirelessly to create solutions for real people, making a tangible difference every day.

For more information about our business, mission, and commitment to diversity, click here.

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