VACANCY FOR REGULATORY AND COMPLIANCE SPECIALIST

NIPD Genetics Public Company Ltd 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 and Compliance Specialist for full time employment.

PROFILEOFTHEIDEALCANDIDATE

The ideal candidate will be able to provide support with the CE marking of company’s clinical diagnostic tests by performing conformity assessment activities and preparing documentation required. You will aid with transitioning from MDD to MDR and the associated remediation work involved. This candidate will also be a point of contact for Data Protection advice to colleagues at all levels including providing advice on sharing and disclosure of personal information. 

RESPONSIBILITIES

• Support compliance and regulatory activities related to notified bodies
• Remain up to date with industry regulations
• Create and maintain technical file documentation for CE marking
• Liaise with all company departments to develop and maintain procedures and policies relating to the handling and processing of data, ensuring the organization complies with all obligations under GDPR
• Apply GDPR and data protection best practice to practical processes at all organizational levels, through appropriate, proactive communication and awareness-raising
• Provide advice on documentation such as privacy policies, data protection impact assessments, legitimate impact assessments, data transfers, direct marketing rules, data processing agreements, data protection clauses in contracts and records of processing activities
• Write concise, structured reports and develop clear briefing materials
• Detail-oriented approach needed to recommend and implement strategic improvements on a range of data privacy and data protection issues
• Able to work in an environment that is often under pressure of competing deadlines and priorities

REQUIREMENTS

• Bachelor's degree in life science or engineering or in regulation
• Master’s degree will be considered an advantage
• Experience in regulatory and compliance in medical industry/biotechnology or in MDD/MDR requirements is considered an advantage
• Knowledge of GDPR with proven experience of applying such legislation in a practical business context will be considered an advantage
• Fluent in both English and Greek languages

APPLICATIONS

To apply please forward your application with subject: Vacancy For Regulatory and Compliance Specialistto NIPD Genetics Public Company Ltd at the following e-mail address: hr@nipd.com. Your application should include a detailed curriculum vitae together with the names of two referees and a cover letter.

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

All applications are strictly confidential.