PQE Group is inviting experienced Medical Device professionals across India to join its growing global team through 100% Remote Freelance/Contract opportunities. Candidates will work remotely from anywhere in India while collaborating with international teams operating in the US EST time zone.

If you have expertise in FDA 21 CFR Part 820, ISO 13485, ISO 14971, EU MDR, SaMD, IEC 62304, Design Controls, Quality Assurance, Regulatory Affairs, Clinical Affairs, or Medical Device Validation, this is an excellent opportunity to work on global regulatory and compliance projects.

These remote medical device jobs offer professionals the flexibility of contract work while contributing to international healthcare and regulatory excellence.

PQE Group Medical Device Freelance Openings

PQE Group is hiring for the following contract positions:

• Design Controls & DHF Remediation Specialist
• Quality & Regulatory Compliance Engineer
• Risk Management Engineer
• V&V & Process Validation Engineer
• Regulatory Documentation & Lifecycle Expert
• Clinical & Post-Market Surveillance (PMS) Specialist
• Cross-Functional Project Manager
• Quality Training & Continuous Improvement Lead

Job Location

• Location: Remote (Work From Anywhere in India)
• Time Zone: US EST Working Hours
• Employment Type: Freelance / Contract

Key Responsibilities

Depending on the role, selected candidates will be responsible for:

Design Controls & DHF Remediation Specialist

• Conduct Design History File (DHF) gap assessments.
• Ensure complete traceability of design documentation.
• Support FDA and ISO compliance initiatives.

Quality & Regulatory Compliance Engineer

• Prepare organizations for regulatory audits.
• Maintain compliance with FDA 21 CFR Part 820.
• Support ISO 13485 and EU MDR implementation.

Risk Management Engineer

• Develop and maintain ISO 14971 Risk Management Files.
• Perform FMEA and risk assessments.
• Link risk documentation with design controls.

V&V & Process Validation Engineer

• Execute Design Verification & Validation activities.
• Prepare IQ/OQ/PQ validation protocols.
• Support manufacturing process validation.

Regulatory Documentation & Lifecycle Expert

• Prepare Technical Documentation for CE Marking.
• Support global product registrations.
• Maintain lifecycle documentation.

Clinical & PMS Specialist

• Manage PMCF activities.
• Perform complaint investigations.
• Monitor post-market surveillance trends.

Cross-Functional Project Manager

• Coordinate R&D, QA, Manufacturing and Regulatory teams.
• Track project timelines and deliverables.
• Ensure successful execution of medical device projects.

Quality Training & Continuous Improvement Lead

• Deliver CAPA and DHF training.
• Improve Quality Management System (QMS) processes.
• Drive continuous improvement initiatives.

Required Qualifications

Candidates should possess:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, Biomedical Engineering, Pharmacy, or related disciplines.
• Strong experience in Medical Device Quality and Regulatory Affairs.
• Expertise in:
  • FDA 21 CFR Part 820
  • ISO 13485
  • ISO 14971
  • EU MDR / IVDR
  • Design Assurance
  • Technical Documentation
  • Quality Management Systems
• Experience in one or more of:
  • SaMD
  • IEC 62304
  • In-Vitro Diagnostics (IVDs)
  • Combination Products
  • Class II & Class III Medical Devices

Why Join PQE Group?

• 100% Remote Work from Anywhere in India
• Global Medical Device Projects
• Flexible Freelance Engagement
• International Regulatory Exposure
• Work with Global Experts
• Opportunity to build experience across FDA, MDR and ISO compliance projects
• Competitive Contract Compensation

How to Apply

Interested candidates should email their updated CV along with the following details:

• Current CTC
• Expected CTC
• Notice Period
• Open to Freelance/Contract? (Yes/No)

Email: suneel.kumar@pqegroup.com