Regulatory & Design Assurance Engineer - On the Job Training

Qualifications and Experience:  

• Bachelor’s degree in biomedical engineering, Electrical Engineering, Computer Engineering, or a related field
• Basic understanding of engineering product development processes
• Familiarity with requirements documentation and engineering traceability concepts Understanding verification and validation practices in engineering systems
• Awareness of engineering risk management principles
• Familiarity with documentation tools and collaborative engineering workflows Soft Skills
• Structured and analytical thinking
• Strong attention to detail and documentation discipline
• Effective communication with multidisciplinary engineering teams
• Ability to manage complex technical documentation
• Curiosity and motivation to learn regulated product development processes

Language Requirements

• English (fluent written and verbal) – Mandatory
• Arabic (fluent written and verbal) – Mandatory

The Regulatory & Design Assurance Engineer (Fresh Graduate) supports the development of NEXA wearable medical devices by ensuring that product design, risk management, verification, and regulatory documentation align with medical device standards and design control requirements.

The role focuses on regulatory readiness, design assurance, risk management, verification & validation coordination, and product quality throughout the product development lifecycle. Working closely with hardware, embedded software, machine learning, software, clinical, and regulatory teams, the engineer helps ensure that NEXA products are developed with clear traceability, structured verification evidence, and compliance with international medical device standards.

This role provides hands-on exposure to medical device development practices including ISO 13485 design controls, ISO 14971 risk management, verification & validation engineering, and regulatory documentation frameworks, as well as broader regulatory lifecycle considerations such as manufacturing readiness, labeling, and regulatory submissions.

1. Regulatory Documentation & Submission Support

Support preparation and maintenance of regulatory and technical documentation.

Responsibilities include, and are not limited to:

• Maintain structured technical documentation / design history file for NEXA products

• Support mapping of development activities to applicable regulatory standards

• Assist in organizing documentation required for regulatory reviews or submissions

• Support preparation for regulatory pathways such as CE marking and FDA submissions

• Ensure documentation aligns with applicable standards such as ISO 13485, ISO 14971, IEC 60601 …etc. – where applicable.

2. Regulatory Lifecycle Support (Manufacturing, Labeling & Product Release)

Support regulatory and compliance considerations related to product manufacturing and market readiness.

Responsibilities include, and are not limited to:

• Assist in organizing documentation required for manufacturing readiness and product release

• Support documentation related to device labeling, instructions for use (IFU), and product packaging information

• Assist in ensuring labeling and product information align with regulatory requirements and standards

• Support preparation of documentation required for regulatory submissions and certification processes

• Help maintain records related to product configuration, manufacturing documentation, post-market surveillance, and regulatory traceability

3. Risk Management (ISO 14971)

Support the implementation of structured product risk management practices.

Responsibilities include, and are not limited to:

• Maintain and update the product risk management file

• Participate in hazard analysis and risk assessment activities with engineering teams

• Document risk controls and mitigation strategies defined by engineering teams

• Ensure traceability between identified hazards, risk controls, and verification activities

• Support periodic review and updates of risk documentation during development

4. Verification & Validation (V&V) Coordination

Support the planning and documentation of product verification and validation activities.

Responsibilities include, and are not limited to:

• Assist in defining verification plans and test protocols in collaboration with engineering teams

• Track verification and validation activities across hardware, firmware, ML, and software subsystems

• Ensure test results and validation evidence are linked to requirements and risk controls

• Support engineering teams in developing test protocols, validation procedures, and analysis methods used during verification and validation activities

• Assist in reviewing and organizing validation results to support engineering decisions and regulatory evidence

• Organize verification reports and validation documentation

5. Product Quality & Design Assurance

Support product quality activities within the development lifecycle.

Responsibilities include, and are not limited to:

• Support documentation and tracking of design reviews and engineering decisions

• Assist in maintaining design change records and traceability of design updates

• Ensure verification and validation evidence meets internal quality and documentation standards

• Support preparation of product documentation for internal reviews, audits, and compliance checks

6. Cross-Functional Engineering Collaboration

Work closely with engineering and product teams to ensure design activities remain compliant and traceable. With Hardware & Embedded Engineering

• Capture verification results related to hardware and firmware testing

• Support documentation of design outputs and integration testing With Machine Learning & Software Teams

• Support documentation of algorithm validation and system performance metrics

• Maintain traceability between ML components and system requirements With Clinical & Research Teams

• Support documentation related to product validation in pilot trials or clinical studies

• Assist in organizing validation evidence generated from research activities With Quality & Compliance Teams

• Support compliance documentation and internal review preparation

• Help ensure product documentation is audit-ready

7. Agile Development & Engineering Tools

• Participate in agile development processes including sprint planning, standups, reviews, and retrospectives

• Track work items and tasks using Jira or similar project management tools

• Maintain technical and regulatory documentation using Notion or documentation platforms

• Follow structured engineering workflows that support traceability and compliance

8. Documentation & Technical Reporting

• Maintain clear and structured documentation supporting product development and compliance

• Document verification results, design updates, and risk management changes

• Organize technical documentation required for audits, design reviews, and regulatory assessments

• Ensure engineering documentation remains accurate and traceable throughout development