The individual will be responsible for the maintenance of our Quality Management System, creating and updating company SOP’s and ensuring their correct and effective implementation across the various teams.

The QA/RA Manager will also support with the regulatory work being undertaken and be the direct point of contact for all regulatory and quality needs across the organization.

Job Responsibilities:

• Maintain and update all company Standard Operating Procedures in our Quality Management System and ensure all departments are working according to them
• Responsible for all documentation control in QMS per internal and external regulatory requirements
• Responsible for training employees on relevant processes, and guiding them on writing all company procedures, specifications, instructions, etc.
• Regulatory support and registration of the company products in various countries, including the USA, Asia, Europe & Latin America.
• Managing annual ISO audit and all work associated working with various departments and personnel to conduct internal audits, management review, etc.
• Responsible for approval of finished product release
• Responsible for complete management of company’s Quality Compliance to ensure compliance with regulatory agencies and all applicable standards worldwide.

Requirements:

• 5+ years experience as a QA Manager or similar role
• Knowledge and experience managing company ISO Audits (i.e ISO 13485)
• Experience with FDA processes, including 510k and PMA processes
• Experience with writing and implementing SOPs
• Experience initiating and completing CAPAs and reports, performing internal and external audits and trainings
• Experience effectively enforcing rules, regulations and order within a company
• Past Quality assurance experience from a medical device company
• Knowledge of regulatory requirements, and experience in drafting, submitting and maintaining regulatory related files
• Relevant education (BSc. in related field and quality related education)
• High-level English required (Native tongue preferred)