Manager - Medical Device Quality & Regulatory Documentation

Dash Technologies Inc; Hinoba-an; On-site; PHP 7,524,000 - 9,404,000; Full time

Job summary

Dash Technologies Inc seeks an experienced Manager to lead medical-device quality and regulatory documentation. The role requires 7+ years in the field and hands-on FDA submission work across Class I-III devices.

You will develop strategies, compile FDA submissions, and ensure audit-ready documentation aligned with ISO 13485 and FDA QMSR. Responsibilities include maintaining DHFs, traceability, and risk management while coordinating with clients, engineers, laboratories, and vendors.

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, 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.

Responsibilities

• Review FDA classification, regulation number, product code, regulatory pathway and submission requirements.
• Develop documentation strategies for Class I, II, III devices.
• Prepare FDA 510(k), De Novo, PMA, and other regulatory submission documents.
• Conduct predicate-device searches and prepare Substantial Equivalence comparisons.
• Prepare Intended Use, Indications for Use and device descriptions and regulatory plans.
• Develop Design History Files, Medical Device Files, technical files, and product-release documentation.
• Prepare user needs, system/software requirements, architecture, design specs, and traceability matrices.
• Develop IEC 62304 software lifecycle documents including V&V, maintenance and release records.
• Prepare ISO 14971 risk documentation including FMEAs and risk management reports.
• Review cybersecurity, usability, electrical-safety, biocompatibility, verification and validation docs.
• 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 and supplier quality.
• Coordinate documentation with clients, engineers, labs, clinical teams and vendors.
• Manage FDA questions and submission updates through clearance or approval.

Skills

Regulatory affairs

FDA submissions

Quality management

Technical writing

Education

Bachelor's degree in Engineering, Life Sciences, Quality, Regulatory Affairs, or related field

Tools

eSTAR

MasterControl

Jama

Polarion

Jira

Azure DevOps

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