Regulatory Affairs & Quality Assurance Specialist

Job Purpose:
Responsible for maintaining and ensuring that the Company’s Quality Management System complies with ISO 13485 ,FDA and international medical device regulatory standards.

Duties and Responsibilities
• The QA & RA Specialist will execute regulatory affairs and compliance activities ,audits from NB’s including communication for incident reports, registrations, etc.
• Establish, manage and maintain compliance with FDA QSR, including establishment registration, new product submissions, CAPA System.
• Establish, manage and maintain compliance with MDD 93/42/EEC directive, including CE Mark applications via Technical Files.
• Responsible for the quality and regulatory control for products
• Manage and maintain compliance to ISO13485 requirements.
• Responsible for responding and reporting incidents to all approved markets.
• Responsible for the Customer Complaint System.
• Responsible for managing product failures and appropriate corrective actions.
• Responsible for defining the Company’s quality goals each year.
• Ensure that personal training records are maintained in conjunction with HR department.

Education and Experience
• Degree in pharmaceutical chemistry or similar science or related technical discipline.
• Knowledge and application of: ISO 13485, Medical Devices Directive applicable standards required by the European and non-European market.
• Good English language skills.
• Experience in audit activities.
• Good interpersonal and professional communication skills.
• Minimum of one to three years related experience required.
• Ability to work from designated office for collaborative/interactive fulfilment of duties.
• Flexibility and resilience in the face of constraints, frustrations or adversity.
• Appropriately and directly interact with other staff members and/or outside associates.
• Operate office equipment such as computer and telephone.
• Attend and participate in meetings via phone, computer, or in person.

You can send your CV to:. info@camark.gr