Job Description

Job Summary

Job Purpose:

To assist with maintaining a company-wide quality management system (QMS) as well as assisting with medical device certification(s), including, but not limited to ISO13485, CE and FDA. This includes maintaining documentation of specifications and procedures, advising the internal team on regulatory and quality issues, and keeping up to date with the latest local and international standards. Ensuring registration and compliance with the relevant authorities/notified bodies.

Minimum education (essential):

• Certificate or higher in health sciences, or biomedical technology, business administration (experience essential), or equivalent qualification.

Minimum education (desirable):

• ISO 13485* certificate, or
• ISO 13485* internal auditor certificate, or
• ISO 14971* certificate, or
• IEC 62304 certificate.

Minimum applicable experience (years):

Qualified professionals

• Certificate = 5 years minimum
• Diploma = 3 years minimum
• Degree = 2 years minimum with Quality Management & Assurance experience (minimum 1 year) in developing and implementing Quality Management Systems according to EN ISO 13485.

Required nature of experience:

• Quality Management Systems according to ISO 13485, , or similar (ISO 17025 / 21 CFR 820 / MDR 2017/745) -
• Solid knowledge of the regulatory framework applying to medical devices in either SA, or USA, or EU market.
• Risk Management
• Experience in the implementation of EN 62304 requirements within a Quality Management System (beneficial)
• Experience in the preparation of Technical Documentation for FDA or CE marking purposes of SaMDs (beneficial)
• Internal auditor experience (beneficial)
• Experience in the medical device industry or technology industries (beneficial).

Skills and Knowledge (essential):

• Knowledge of ISO 13485, and , MDR or, UKCA or, FDA
• Excellent computer proficiency ( MS Office 0r GSuite)
• Report and proposal writing skills
• Business process design
• Internal audits (knowledge essential)
• GSuite operations (or an equivalent cloud-based document management tool)
• Good communication and reporting skills
• Self-driven, self-organized and problem-solving oriented.

Essential Competencies:

• Examining Information
• Documenting Facts
• Developing Expertise
• Providing Insights
• Exploring Possibilities
• Meeting Timescales
• Checking Things
• Following Procedures

Important Competencies:

• Adopting Practical Approaches
• Interpreting Data
• Generating Ideas
• Developing Strategies
• Convincing People
• Challenging Ideas
• Making Decisions
• Showing Composure
• Embracing Change
• Managing Tasks
• Producing Output
• Taking Action

Quality Management

• Define quality procedures in conjunction with operating staff.
• Drive the development, improvement and implementation of the company Quality Policy and Quality Management System.
• Set up and maintain controls and documentation procedures.
• Conduct internal audits on existing processes (if applicable).
• assist with supplier management in line with QMS processes
• Collaborate and assist with management review meetings in line with QMS processes.
• Support in keeping medical device risk files and device literature valuation up to date.
• Conduct training (formal or informal) on the QMS system and associated processes.
• Manage internal change management to drive adoption of QMS within the company.
• Liaise with internal teams and process owners in order to drive quality management within the company.
• Any other lawful tasks required by management.

Regulatory Compliance

• Assist in maintaining facility and product registrations at relevant bodies in active territories.
• Assist with compliance of medical devices to relevant medical device regulations.
• Assist in aligning post market surveillance activities/reports with QMS processes.
• Research and implement (if and when required) any new regulatory requirements and compliance related topics, processes and documentation.
• Compile relevant records as is necessary for compliance to ISO, CE, FDA (and other) standards and requirements as is applicable to all products.
• Compile and disseminate information to relevant employees, training them as necessary on regulatory requirements.
• Assist in communicating with notified bodies regarding quotes, schedules, documentation and audits.
• Support software development requirements for medical device software, where applicable/relevant.
• Provide expert, accurate guidance to stakeholders/top management on regulatory pathways
• Accomplish objectives by establishing plans and results; reviewing progress and making mid-course corrections to ensure optimal outcome.

Record - Keeping

• Assist and maintain documentation, SOPs, and records within the various departments.

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