Details of the Organization

HCLTech is a global technology company, home to more than 223,000 people across 60 countries, delivering industry-leading capabilities centered around digital, engineering, cloud and AI, powered by a broad portfolio of technology services and products.

Details of the Job/Internship

HCLTech is hiring for the position of Compliance Manager with 10+ years of experience to join their office in Noida. 

Role and Responsibilities

• Lead internal audits for medical device programs, ensuring full compliance with ISO 13485, FDA 21 CFR Part 820, and EU MDR requirements.
• Investigate non-conformances, conduct root cause analyses, and implement effective corrective and preventive actions (CAPA).
• Review and validate onboarding checklists to confirm alignment with regulatory standards for FDA and EU MDR compliance across all devices.
• Oversee compliance processes related to shipping, labeling, and depot operations for both investigational and commercial medical devices.
• Serve as the primary point of contact during ISO 13485 audits and coordinate seamlessly with logistics teams and external auditors.
• Monitor global regulatory developments (FDA, EMA, EU MDR) and proactively update internal quality systems and SOPs to maintain compliance.
• Administer the Electronic Document Management System (EDMS), ensuring smooth operations, timely user support, and system maintenance.
• Manage the complete lifecycle of controlled documents, including version control, scheduled reviews, and audit preparedness.
• Foster compliance culture across cross-functional teams, delivering training and guidance to enhance risk awareness and regulatory understanding.
• Effectively communicate complex compliance risks to non-technical stakeholders, demonstrating strong problem-solving and virtual collaboration skills.

Eligibility

• Minimum 10 years of experience in medical device compliance, quality assurance, or regulatory affairs within the pharmaceutical, biotech, or medical device industry.
• In-depth knowledge and hands-on experience in ISO 13485 implementation, regulatory audits, and maintaining compliant quality management systems.
• Strong understanding of FDA 21 CFR Part 820, EU MDR (Regulation (EU) 2017/745), and applicable international standards for medical devices.
• Experience in clinical and commercial logistics, including depot management and global shipping protocols.
• Proficiency in document control within GxP environments (GMP, GVP, GCP), including change control and IT compliance.
• Familiarity with EU Authorized Representative requirements, UDI regulations, and product registration procedures.
• Strong analytical, documentation, and organizational skills with the ability to manage multiple priorities in a regulated environment.
• Excellent communication and stakeholder engagement capabilities, with a proven ability to lead audits and guide cross-functional teams.

Salary/Stipend

Compensation details will be finalized during the interview process with the selected candidate.

Type of Opportunity

Fulltime

Country

India

Address

Noida, Uttar Pradesh, India

Application and Registration Details

After you submit your application, you will receive the next steps in the process via email. Please follow the instructions provided to complete your application.

Incase you find any issue with the application process, please contact: [email protected] 

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