Manager - Medical Device Quality & Regulatory Documentation

Dash Technologies Inc; Ahmedabad District; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Dash Technologies Inc. seeks an experienced Manager for Medical Device Quality & Regulatory Documentation to lead FDA submissions and related quality systems efforts in a fast-paced environment.

You will review device classifications, prepare 510(k), De Novo, PMA documents, and develop documentation strategies across Class I-III devices, ensuring compliance with ISO 13485/14971 and FDA QMSR. Collaboration with engineering, clinical, and supplier teams is essential.

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field.
• 7+ years of medical-device quality or regulatory experience.
• Hands-on experience identifying FDA device classification and regulatory pathways.
• Direct experience preparing and submitting FDA 510(k)s.
• Experience with Class I, II, III documentation.
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304, design controls, FDA QMSR.
• Experience developing complete, audit-ready documentation.

Responsibilities

• Review the device's intended use to identify FDA classification, regulation number, product code, and submission requirements.
• Develop documentation strategies for Class I–III devices.
• Prepare FDA 510(k), De Novo, PMA, and other regulatory documents.
• Conduct predicate-device searches and prepare Substantial Equivalence comparisons.
• Prepare Intended Use, Indications for Use, device descriptions, regulatory plans, and traceability matrices.
• Develop Design History Files, Medical Device Files, technical files, and product-release documentation.
• Prepare system/software requirements, architecture, and traceability matrices.
• Develop IEC 62304 and ISO 14971 documentation including risk management records.
• Coordinate documentation with clients, engineers, laboratories, and vendors.
• Manage FDA questions and submission updates through clearance or approval.

Skills

Regulatory documentation

FDA submissions

Quality systems

Technical writing

Education

Bachelor's degree

Tools

MasterControl

Jama

Polarion

Jira

Azure DevOps

Greenlight Guru

Job description

Manager - Medical Device Quality & Regulatory Documentation

7+ Years

Full-Time

About Dash Technologies

Founded in 2010 and headquartered in Dublin, Ohio, USA, Dash Technologies Inc. is a healthcare-focused technology company with a global delivery center in Ahmedabad, India. For more than 15 years, Dash has partnered with healthcare and MedTech organizations to design and engineer digital health solutions spanning Medical IoT, device and system integration, connected applications, artificial intelligence, machine learning, and data analytics. An ISO 9001-certified company, Dash combines strong engineering capabilities with practical execution to advance healthcare’s digital transformation and improve care delivery.

DASH Technology is seeking an experienced professional to lead medical-device documentation and FDA regulatory submissions for Class I, Class II, and Class III devices.

Key Responsibilities

• Review the device's intended use and claims to identify the appropriate FDA classification, regulation number, product code, regulatory pathway, and submission requirements
• Develop documentation strategies for Class I, Class II, and Class III medical devices
• Prepare FDA 510(k), De Novo, PMA, and other regulatory submission documentation
• Conduct predicate-device searches and prepare Substantial Equivalence comparisons
• Prepare Intended Use, Indications for Use, device descriptions, regulatory plans, claims matrices, and eSTAR packages
• Develop Design History Files, Medical Device Files, technical files, and product-release documentation
• Prepare user needs, system/software requirements, architecture, design specifications, and traceability matrices
• Develop IEC 62304 software lifecycle documents, including software plans, requirements, V&V, anomaly, configuration-management, maintenance, and release records
• Prepare ISO 14971 risk documentation, including hazard analyses, FMEAs, risk controls, benefit-risk analyses, and Risk Management Reports
• Review cybersecurity, usability, clinical, electrical-safety, biocompatibility, verification, and validation documentation
• Maintain traceability between user needs, requirements, risks, design outputs, tests, defects, and release evidence
• Support ISO 13485 and FDA QMSR documentation, including document control, CAPA, nonconformances, change control, supplier quality, audits, and inspection readiness
• Coordinate documentation with clients, engineers, laboratories, clinical teams, and third-party vendors
• Manage FDA questions, Additional Information requests, and submission updates through clearance or approval

Required Qualifications

• Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or a related field
• 7+ years of medical-device quality or regulatory experience
• Hands-on experience identifying FDA device classification and regulatory pathways
• Direct experience preparing and submitting FDA 510(k)s
• Experience with Class I, Class II, and Class III medical-device documentation
• Strong knowledge of ISO 13485, ISO 14971, IEC 62304, design controls, and FDA QMSR
• Experience developing complete, traceable, audit-ready, and submission-ready documentation
• Excellent technical-writing, document-review, communication, and project-management skills

Preferred Qualifications

• Experience with De Novo or PMA submissions
• Experience with SaMD, medical-device software, medical imaging, or connected devices
• Knowledge of FDA eSTAR and medical-device cybersecurity requirements
• Experience with Greenlight Guru, MasterControl, Jama, Polarion, Jira, or Azure DevOps