Regulatory Affairs & Quality Assurance Specialist

Camark is a company born in 2016 in Greece and is part of the Omnia S.r.l. group. Our mission is the production of surgical sutures for the dental market, with high quality materials and certificated production techniques. 

Currently, there is a job opening for a full-time 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

• 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