Q&R Specialist

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.

We are looking for a Quality and Regulatory Specialist for our sales' organization with headquarters in Prague.

The person in the role will be responsible for a region of central and south Europe.

Job Responsibilities and Essential Duties

Market Access and Regulatory

• Regulatory and Product Registration SME (Subject Matter Expert )
• Ensure product registration certificates are collected and up to date,
• Follow up regulation and standard changes for the responsible markets, inform related and key people in the company, ensure proactive actions are taken when needed to ensure timely compliance.

• Implement medical device registration/re-registration activities in the hub, manage the registration activities in distributor markets in close collaboration with our distributors and manufacturing sites, ensure timely market access.
• Regulatory impact assessment for product changes

Field Actions (FA) & Customer Product Complaint

• Coordinate FAs and follow up actions, ensure all related actions are done in timely manner.

• Reporting FAs to local authorities of affected countries when necessary, at the initial and closure phase, by considering local requirements, ensure authority questions are responded in timely manner
• Provide progress information to manufacturer about open FA
• Update FA tracker and TW regularly
• Archive FA records locally
• Monitor SSU if customer product complaints are reported to manufacturers timely, and take appropriate improvement actions about reporting times when needed,
• Liaise with local authorities when required, in cooperation with manufacturer.
• Ensure SSU provides customer response for complaints when needed.

Minimum Requirements

• 2-3  years’ Experience Regulatory operations in Medical Device, alternatively under Pharma or CRO
• University Degree, preferably from Scientific discipline.
• Experience in Market Access and registration activities ( multiple countries)

Required Knowledge, Skills, and Abilities

• Working knowledge of medical device regulations (EU MDR, MDD, GDP) with a willingness to expand expertise
• Knowledge of ISO 13485:2016 and ISO9001:2015
• Familiarity with SAP (an advantage, but not required)
• Proficiency in MS Office (Excel, PowerPoint, and Word )

• Good level of Czech & English spoken and written
• Team-oriented mindset and willingness to collaborate
• Detail-oriented, diligent and responsible
• Ability to manage multiple tasks and prioritize work effectively
• Strong communication and presentation skills
• Well-organized with a quality-focused approach

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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.