Natus Sensory India has announced an exciting opportunity for experienced quality and regulatory professionals. The company is hiring a Document Control Analyst for its Quality Assurance & Regulatory Affairs (QARA) department. This remote position offers professionals the chance to work with global teams across Europe and the United States while supporting quality systems, engineering changes, and regulatory compliance activities.
Candidates with experience in Quality Management Systems (QMS), change control processes, medical devices, and regulatory documentation are encouraged to apply.
Job Overview
| Details | Information |
|---|---|
| Position | Document Control Analyst |
| Department | Quality Assurance & Regulatory Affairs (QARA) |
| Company | Natus Sensory India |
| Location | Remote (Future office presence in Bengaluru) |
| Experience | 3–5 Years |
| Qualification | Diploma/Degree in Quality or Equivalent |
| Employment Type | Full-Time |
| Travel Requirement | Less than 5% |
| Industry | Medical Devices & Healthcare Technology |
About Natus Sensory India
Natus Sensory is a globally recognized manufacturer of medical devices and healthcare software solutions. The company develops innovative diagnostic, screening, and treatment technologies focused on sensory and neurological disorders. Its products support healthcare professionals worldwide in improving patient outcomes through advanced diagnostic solutions.
Key Responsibilities
The selected Document Control Analyst will be responsible for managing engineering change processes and ensuring regulatory compliance across product lifecycle activities.
Change Control & Impact Assessment
- Conduct change impact analysis on product safety and performance.
- Assess software functionality changes and regulatory implications.
- Support engineering change notice (ECN) activities.
Documentation & Compliance
- Review and maintain technical documentation.
- Ensure compliance of:
- Bill of Materials (BOM)
- CAD Documentation
- Verification Reports
- Validation Reports
- Maintain adherence to Quality Management System requirements.
Quality Risk Management
- Identify quality risks associated with product changes.
- Develop mitigation strategies and corrective actions.
- Support continuous quality improvement initiatives.
Testing & Validation Support
- Coordinate with QA teams for regression testing activities.
- Verify readiness before implementation of changes.
- Monitor change effectiveness post-deployment.
Change Control Board (CCB) Support
- Prepare documentation for Change Control Board meetings.
- Participate in change review discussions.
- Track stakeholder readiness and implementation status.
Process Improvement
- Analyze quality metrics and change control trends.
- Present findings during management review meetings.
- Recommend process enhancements to improve efficiency and compliance.
Required Qualifications
Applicants should possess:
- Diploma or Bachelor’s Degree in Quality, Engineering, Life Sciences, or related discipline.
- Strong understanding of document control and change management processes.
- Excellent analytical and problem-solving skills.
- Ability to work independently in a remote environment.
- Strong English communication skills.
Preferred Skills
The ideal candidate should have experience with:
- Quality Management Systems (QMS)
- ISO 9001 Standards
- FDA Regulations
- Medical Device Regulation (MDR)
- Medical Device Directive (MDD)
- MDSAP Requirements
- Product Lifecycle Management (PLM) Tools
- IT Service Management (ITSM) Systems
- Risk Management and Regulatory Documentation
Experience Required
Natus Sensory is seeking professionals with:
- 3 to 5 years of relevant experience.
- Experience handling complex quality and compliance activities.
- Exposure to cross-functional collaboration with QA, Engineering, Manufacturing, and Regulatory teams.
- Ability to manage multiple projects simultaneously.
- Experience presenting technical information and compliance data.
Salary and Benefits
Based on current market trends for medical device quality professionals in India, the estimated salary range for this role is:
₹8 LPA – ₹14 LPA
Benefits include:
- Comprehensive medical insurance
- Family healthcare coverage
- Gratuity benefits
- Paid leave as per labor laws
- Performance-based incentives
- Company-provided equipment
- International work environment
- Career growth opportunities in medical devices and regulatory affairs
Why Join Natus Sensory?
- Work with a global medical technology company.
- Collaborate with international teams across Europe and North America.
- Opportunity to contribute to innovative healthcare solutions.
- Remote flexibility with future Bengaluru office opportunities.
- Strong focus on quality, compliance, and professional development.
How to Apply
