Quality and Regulatory Compliance Manager

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:

Quality and Regulatory Compliance (QRC) Manager role will be responsible from the Sales and Service Unit (SSU) located in Istanbul-Turkiye, will report to CEE Region QRC Director and report in dotted-line to SSU Managing Director. The role will cover QRC activities for Turkiye, Israel and Central Asia countries, will ensure company QRC strategy is implemented in the SSU, will be responsible from the following activities;

• Implement medical device registration/re-registration activities in Turkiye, manage the registration activities in distributor markets (Israel and Central Asia countries) in close collaboration with our distributors and manufacturing sites, ensure timely market access,
• Follow up regulation and standard changes for the responsible markets and take proactive actions when needed to ensure timely compliance,
• Manage product reimbursement activities in Turkiye, apply for new reimbursement when applicable and follow up actions,
• Follow up initiated Field Action activities with SSU and distributors, support SSU for timely closure,
• Ensure timely authority reporting for PMS activities (customer complaints, field actions) for all the responsible countries,
• For customer product complaints, support SSU about being compliance to global procedure,
• Ensure an effective QMS system is in place and followed by the SSU, support continuity of ISO 13485 and ISO9001 matrix certificates,
• Develop quality mindset and awareness within the SSU,
• Conduct QMS and authority audits, manage CAPAs and ensure timely actions taken,
• Provide procedure and regulation trainings to SSU people,
• Support SSU to meet Quality KPIs, and take necesary actions when needed,
• Ensure proper supplier control activities are in place in close collaboration with related departments, implement supplier audits when required and follow up audit actions, maintain approved supplier list,
• Within the scope of medical device sales, advertising and promotion regulation ensure timely notification of scientific and educational activities via the Ministry of Health EBS system, making and following up the applications when needed for Responsible Manager, Clinical Support and Sales people,
• Support SSU to keep TSE HYB and TSE 868-5 certificates, attend TSE audits and take needed actions.

Qualifications:

• University degree; scientific discipline is preferred,
  Min. 4-5 years of experience in Regulatory and Quality System Management in medical device industry,
• Experience in internal and/or supplier audits,
  Good knowledge of medical device regulations (local regulations for the responsible countries and EU MDR), ISO 13485 and ISO9001,
• Having internal auditor certificate for ISO13485/ISO9001 would be an asset,
  Fluent in English (written and spoken)
• Proficient in MS Office (Excel, PowerPoint, and Word)

Abilities:

• Good leadership skills,
• Able to work effective in hybrid working model (based on need working from office & home)
• Multitasking,
• Able to prioritize and triage issues for efficient resolution
• Collaborative team player,
• Strong planning, follow up, reporting and organization skills to achieve accurate and  timely results
  Strong communication and presentation skills

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.