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    • Coordinate regulatory activities and support ongoing medical device projects.
    • We are seeking a Regulatory Coordinator with prior *Johnson & Johnson / DePuy…
    • We are hiring an experienced medical writer with experience in CTD medical writing and experience in clinical development of medicines.
    • 3-7 years of experience in regulatory/medical writing.
    • Draft high-quality medical and regulatory documents in accordance with global guidelines.
    • Job Type: Contract (PRN / As Needed).
    • We are seeking experienced clinical professionals to evaluate AI-generated nursing education content for Intensive Care…
    • At least 0-4 years of experience in regulatory medical writing within the pharmaceutical, biotechnology, or medical device industry.
    • Strong knowledge of medical terminology.
    • Ensure timely completion of medical records.
    • The role involves real-time documentation of patient encounters while…
    • Scientific and medical literacy - demonstrates sufficient scientific/ medical knowledge to check pharmaceutical claims in promotional materials are referenced…
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    • Looking for linguistic candidate who can speak south language.
    • The ideal candidate will be responsible for communicating with patients, monitoring their health…
    • 3+ years of experience in medical editing, scientific editing, medical communications, healthcare content, or pharmaceutical content review.
    • Receive mentorship and feedback from experienced medical writing professionals.
    • Motivated to build a career in medical or scientific writing.
    • 3+ years of experience in medical or pharmaceutical editing.
    • Experience working in a fast-paced agency or medical communications setting.
    • Proven experience in academic/research writing.
    • Candidates must demonstrate strong research ability, structured academic writing skills, and strict adherence to…
    • Document and track regulatory submissions and regulatory authority approval.
    • Provide regulatory support to clients and associate companies.
    • 1–3 years of experience in medical/scientific writing, preferably within a pharma, biotech, or medical communications agency setting.
    • Penchant to write research articles.

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Job Post Details

Regulatory Coordinator – Medical Devices - job post

DEV-X
Remote
₹50,000 - ₹1,00,000 a month

Job details

Pay

  • ₹50,000 - ₹1,00,000 a month

Job type

  • Contractual / Temporary

Shift and schedule

  • US shift

Full job description

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

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