REGULATORY SPECIALIST with Hungarian/Turkish. IE1638

Employer: DK Global Recruitment
Domain:
  • Acquisitions - Logistics - Supplies
  • Pharmacy - Health
  • Job type: full-time
    Job level: 1 - 5 years of experience
    Location:
  • BUCHAREST
  • Updated at: 22.08.2019
    Short company description

    DK Global Recruitment is a multilingual recruitment agency, based in Dublin, Ireland. We specialize in finding European language-speaking jobs for job seekers in many European countries. With years of experience in the multilingual BPO sector, we have developed advanced skills that we use to help Companies relocate candidates globally, and assist candidates to relocate smoothly and find their desired employment.

    Requirements


    • Fluency in English and Turkish or Hungarian
    • Must be highly analytical and able to evaluate, analyse, and summarize large volumes of data and technical material efficiently
    • Preferred 1 - 2 years of experience in Regulatory Affairs, Medical Report Writing, or Regulatory Compliance specific to medical device
    • Knowledge of global regulatory requirements for medical devices desired
    • Ability to communicate clearly both verbally and in writing
    • Excellent organizational and presentation skill & proficient with MS office products

    Responsibilities


    • Assist the central team in preparing regulatory submissions for all countries in scope, both local country reports & MedDev
    • Fully responsible for all local country submissions & MedDev reports for all countries in scope including cover letters as needed
    • Interacts with Health authorities in various enquiries related to device complaints and submissions. Any additional asks from Health Authorities
    • Assist in translation and review of the medical content/language within the reports
    • Maintain knowledge base of existing and emerging regulations, standards, or guidance documents
    • Communicate & interact with various local vendors falling in the purview of contract agreements

    Other info

    Benefits

    • Christmas bonus
    • medical services
    • life insurance
    • MyFlexBen Program – a flexible program based on which each employee will have the opportunity to monthly customize the package by accessing a large variety of benefits available to be ordered via an online platform:
    • Private Pension Plan;
    • Learning and development opportunities (including foreign languages trainings);
    • Meal Vouchers & Gift Vouchers
    • Tourism Vouchers & Tourism offers in Romania;
    • Smart experience (Skydiving, Archery, Horse-riding, Lasertag, Escape Room, etc);
    • Transportation (Bus/Subway subscriptions, gas station cards etc)
    • Special offers vouchers & products (Children&Parents, Sport&Wellness, Telecom&IT, Fashion, Hobby, etc).



    Why use Recruitment Agency

    • You will be contacted within 30 min of your application
    • You are given extra support in preparing for interviews
    • You have a contact person who gives you all the details of the job
    • You can ask for your application feedback anytime via email or phone
    • You don’t have to face the situation where company do not reply to you for days.
    • All our services to job seekers are free of charge. We also offer bonus scheme to candidates.


    DK Global Recruitment is a multilingual recruitment agency, based in Dublin, Ireland. We specialize in finding European language-speaking jobs for job seekers in many European countries.
    Our fully-trained expert recruiters help and advise job seekers throughout the recruitment process, and always treat the candidate as a high priority.
    Our clients are highly-reputed companies with constant growth in the international market and we are pleased to find good employees for them. Thus, you should not hesitate to contact us regarding any kind of queries you have, related to jobs and career advice.