PHARMAFull-time
Medical Device Professionals (Freelance / Contract)
REMOTE (IN)REMOTEPOSTED: 8/6/2026
PHARMAFull-time
HIRING ORGANIZATIONPQE GROUPTechnology
ROLE DEFINITION & RESPONSIBILITIES
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.
Open 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
Key Responsibilities
Conduct Design History File (DHF) gap assessments and ensure complete traceability of design documentation.
Prepare organizations for regulatory audits and maintain compliance with FDA 21 CFR Part 820, ISO 13485, and EU MDR implementation.
Develop and maintain ISO 14971 Risk Management Files, perform FMEA, and link risk documentation with design controls.
Execute Design Verification & Validation activities and prepare IQ/OQ/PQ validation protocols.
Prepare Technical Documentation for CE Marking and support global product registrations.
Manage PMCF activities, perform complaint investigations, and monitor post-market surveillance trends.
Coordinate R&D, QA, Manufacturing, and Regulatory teams to track project timelines and deliverables.
Deliver CAPA and DHF training, improve Quality Management System (QMS) processes, and drive continuous improvement initiatives.
Required Qualifications
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.
REQUIRED VERIFIED SKILLS
FDA 21 CFR Part 820
ISO 13485
ISO 14971
EU MDR
Design Controls
Quality Assurance
Regulatory Affairs
Medical Device Validation
COMPENSATION & REWARDS
Salary: Competitive / Disclosed upon candidate shortlisting
Compensation for these remote freelance and contract roles is competitive based on industry standards for experienced medical device regulatory and quality consultants working US EST hours.
ORGANIZATION CONTEXT & CULTURE
PQE Group is actively hiring for this position.
INDUSTRY: Technology
EXPECTED CAREER ROADMAP
Joining PQE Group offers 100% remote freelance/contract engagement on global medical device projects. Professionals gain valuable international regulatory exposure working alongside global experts across FDA, MDR, and ISO compliance projects.
APPLICATION ADVISORY
Include your updated CV in your email along with your Current CTC, Expected CTC, Notice Period, and explicit confirmation of your availability for Freelance/Contract roles.
RECOMMENDED TRAINING
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READY TO SUBMIT?
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