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Regulatory Specialist (1 year contract)

Getinge

Fatih
Hybrid
TRY 24,000 - 36,000
30+ days ago
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Regulatory Specialist (1 year contract)
Getinge
Fatih
Hybrid
TRY 24,000 - 36,000
Full time
30+ days ago

Job summary

A leading company, Getinge, is looking for a Regulatory Specialist to be based in Istanbul, Turkey. This role involves ensuring compliance with medical device regulations, managing product registrations, and collaborating with various stakeholders. Ideal candidates will have a scientific degree and experience in medical device regulatory activities.

Qualifications

  • 2-3 years of experience in Medical Device Regulatory and UTS activities.
  • Knowledge of ISO 9001 and ISO 13485.
  • Fluency in English required.

Responsibilities

  • Implement medical device registration and monitor compliance.
  • Update regulatory intelligence database.
  • Ensure timely authority reporting for PMS activities.

Skills

Strong communication skills
Result-oriented mindset
Presentation skills
Ability to prioritize

Education

University degree in scientific discipline

Tools

MS Office
Job description

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Select how often (in days) to receive an alert:

Regulatory Specialist (1 year contract)

Date: Jul 16, 2025

Location:

Istanbul, TR

Remote Work: 1-2 days at home (site based)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers – and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Responsibilities:

  • Implement medical device registration and re-registration activities in Turkey, follow up the registration activities in distributor markets (Israel and Central Asia countries) in close collaboration with our distributors and manufacturing sites, ensure timely market access,
  • Monitor changes in medical device regulation and changes in standard for the responsible markets and take proactive actions when needed to ensure timely compliance,
  • Keep the regulatory intelligence database updated following market requirements,
  • Implement and follow up product reimbursement activities in Turkey, apply for new reimbursement when applicable and follow up actions,
  • Ensure timely authority reporting for PMS activities (customer complaints, field actions) for all the responsible countries,

Qualifications:

  • University degree ; scientific discipline is preferred
  • 2-3 years of experience in Medical Device Regulatory and UTS activities.
  • Preferably, medical device registration experience for Israel, Uzbekistan, Kyrgyzstan, Kazakhstan, Turkmenistan and Azerbaijan markets.
  • Knowledge of Quality Standards including ISO 9001 and ISO 13485 Quality Management Systems
  • Internal And/or Supplier Audits Experience Is Preferred
  • Fluent in English (written and verbal)
  • Proficiency in MS Office (Excel, PowerPoint and Word)
  • Strong communication skills, result-oriented mindset, presentation skills and able to be a team player
  • Ability to prioritize and handle multiple tasks at the same time

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.

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* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.

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