Regulatory Coordinator – Medical Devices

Job Title: Regulatory Coordinator – Medical Devices
Location: India (Remote)
Shift: US Timings
Experience: 3–7+ Years
Employment Type: Contract

Job Summary

We are seeking a Regulatory Coordinator with prior Johnson & Johnson / DePuy Synthes experience to support regulatory activities for medical device products in a global environment. The ideal candidate will have strong experience in regulatory documentation, coordination activities, product lifecycle processes, and cross-functional collaboration within a highly regulated medical device setting. This role requires working remotely from India while supporting teams in US business hours.

Key Responsibilities

• Coordinate regulatory activities and support ongoing medical device projects.
• Support preparation, review, and maintenance of regulatory documentation and product files.
• Track regulatory deliverables, timelines, and project milestones.
• Maintain and update documentation within regulatory systems and document repositories.
• Support change management activities, product lifecycle documentation, and compliance processes.
• Collaborate with Regulatory Affairs, Quality, R&D, Marketing, and cross-functional stakeholders.
• Assist with submission documentation and ensure compliance with internal and global regulatory requirements.
• Support audit readiness and documentation requests.
• Prepare status reports and communicate project updates to stakeholders.

Required Qualifications

• Bachelor’s degree in Life Sciences, Biomedical Engineering, Pharmacy, Engineering, or related field.
• 3–7+ years of experience in Medical Device Regulatory Affairs/Regulatory Operations.
• Prior experience supporting Johnson & Johnson / DePuy Synthes projects is required.
• Experience working in regulated environments involving FDA, ISO 13485, EU MDR, and global regulatory requirements.
• Experience with document management systems and PLM tools.
• Strong communication and project coordination skills.
• Ability to work independently in a remote environment.

Preferred Qualifications

• Experience in Orthopedic Medical Devices (mandatory preference).
• Experience with 510(k), CE Mark, Technical File documentation, and global product registrations.
• Familiarity with systems such as Agile PLM, RIM systems, TrackWise, Windchill, or similar tools.
• Experience working with global cross-functional teams.

Additional Requirements

• Must be located in India.
• Must be comfortable working US business hours/US time zone overlap.
• Strong attention to detail and ability to manage multiple priorities.

Pay: ₹50,000.00 - ₹100,000.00 per month

Work Location: Remote