Job Description

Minimum Requirement

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

• ISO 13485* certificate.
• ISO 13485* internal auditor certificate.
• ISO 14971* certificate.
• IEC 62304 certificate.
• Min of 3 years experience with quality management.
• Min 1 year of developing and implementing a Quality Management System according to ISO 13485.
• Knowledge of ISO 13485, MDR, UKCA or, FDA.
• Excellent computer proficiency (MS Office or 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.

Responsibilities
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 the adoption of QMS within the company.
• Liaise with internal teams and process owners 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 and reports with QMS processes.
• Research and implement (when required) any new regulatory requirements and compliance-related topics, processes, and documentation.
• Compile relevant records as 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 and 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 outcomes.

Record - Keeping

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

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