NIPD Genetics is a leading innovative biotechnology company active in the field of developing, engineering, and providing in vitro genetic testing solutions. NIPD Genetics consists of a world class dynamic team of experts with extensive experience in biotechnology, business, human genetics, molecular biology, and bioinformatics. Through Research & Development we are committed to developing improved solutions for the prognosis, prevention, better clinical management, and therapy of genetic diseases. NIPD Genetics is the trusted partner of labs and healthcare professionals worldwide. We provide advanced genetic testing services from our CAP accredited & CLIA certified laboratory.

THEPOSITION

We seek to recruit a Regulatory Affairs & Quality Assurance Specialist for full time employment. This role can be challenging since the selected candidate will need to meet tight deadlines. It can also be rewarding when a new product successfully registered.

PROFILEOFTHEIDEALCANDIDATE

The ideal candidate will be able to provide support with the CE marking of company’s medical devices by performing conformity assessment activities and preparing documentation required. They will be able to provide support with the company’s existing quality management system and prepare relevant documentation required. They will also be involved with new quality standards that the company must comply with. 

RESPONSIBILITIES

• Ensure that company's products comply with the regulations of the regions where they are distributed.

• Ensure that company's products and quality management system comply with standards ISO 9001, ISO 13485, ISO 15189, ISO 27001, ISO 17025 and the standards set by the College of American Pathologists. Interpret these standards and ensure that they are communicated through corporate policies and procedures

• Keep up to date with national and international legislation, guidelines and customer practices

• Compile and maintain regulatory documentation such as technical files/dossiers

• Advise scientists on regulatory requirements and coordinate efforts associated with the preparation of regulatory documents or submissions

• Undertake and prepare for regulatory & quality inspections and participate in internal audits

• Participate in external audits

• Liaise with regulatory authorities, accreditation and certification authorities

• Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures

• Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.

• Review product batch records, specification sheets, or test methods for compliance with applicable regulations and quality standards.

• Analyze and investigate product complaints or reported quality issues to ensure closure in accordance with company guidelines and external regulatory requirements

• Desk-based role involves the close study of scientific and legal documents. You'll work closely with scientific colleagues, often on a project-team basis.

REQUIREMENTS

• BSc in Biological Sciences or related field. A Master’s degree is considered an advantage.

• Understanding of both legal and scientific matters

• The ability to grasp new concepts quickly and to assimilate and evaluate scientific data

• Analytical and problem-solving skills

• Written and oral communication skills

• Attention to detail

• The ability to work under pressure and adhere to strict deadlines

• The confidence to report to management

• Team-working skills

• Integrity and professional approach to work

• An awareness of the IVDR

• An awareness of ISO standards

• Good knowledge of English and Greek languages

APPLICATIONS

To apply please forward your application with subject: Vacancy For Regulatory Affairs & Quality Assurance Specialistto NIPD Genetics Public Company Ltd at the following e-mail address: hr@nipd.com.

For further information, please contact the Human Resources Department at Tel. 22266888 or visit www.nipd.com.

All applications are strictly confidential.