Manager, Medical Device Quality & Regulatory Submissions

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

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.