RAQA SPECIALIST based in Dubai / Bucharest (Romania) / Newbury (England) in București at Stryker Corporation

Date Posted: 2/11/2020

Job Snapshot

Job Description

The Job’s Mission

The Regulatory Affairs & Quality Assurance (RAQA) Specialist is responsible to interface with key members of the Quality organisation and assist in implementation of regulatory strategies as defined by MEA business team and communicated through EMEA central regulatory group.

Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Collects all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff.

Key Activities & Accountabilities

  • Obtain product registration dossiers from EMEA Central RA and tailor them to meet country registration requirements
  • Develop close collaboration and communication with central RA groups in EEMEA to ensure timely execution of the MEA RA plan.
  • Communicate with Stryker consultants and distributors across MEA to track and ensure timely dossier submission to the relevant authority
  • Assist Stryker Customer Service team and local dealers in preparing country specific regulatory documentation for custom clearance in MEA region
  • Create and maintain registration database for MEA countries.
  • Responsible for the local demo process including ordering & maintenance of Stryker MEA demo inventory.
  • Ensure complete trace-ability and storage of the products according to the ISO13485:2016 standard.
  • Intermittently support ISO13485:2016 implementation project.
  • Support in preparation and execution of yearly internal and external audits.

Education

  • A minimum of a B.S degree in science/engineering, or related field and at least 2-3 years’ experience in an international organizational business environment

Experience

  • Quality-focused experience within medical device industry
  • Prior experience of product registration of Medical device in MEA is preferred
  • Any experience in a MD area (also operational environment, good understanding of MD business and processes)
  • Experience in International Standards in particular: ISO13485 is desirable.
  • Proficiency in English
  • Strong project management skills
  • High ethical standards and integrity
  • Excellent interpersonal relationship building skills
  • Process consciousness
  • Good analytical and problem-solving skills
  • Action oriented, achiever, result driven
  • Good communication skills
  • Business orientated

Work From Home: Not available

Travel Percentage: 10%

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