Regulatory Affairs Specialist

GETINGE GROUP

Ever since Maquet's founding in Germany in 1838, it has helped hospitals with innovative products such as the first motorized operating table. A Maquet table was used for the first heart transplant surgery in 1967, in South Africa. Firsthand understanding of clinical challenges and continuous optimization of its products established Maquet as a leading provider of medical systems. 

Today Maquet is a product brand within Getinge. The Maquet brand provides a broad range of products and innovative treatment solutions and infrastructure functions for extremely demanding hospital departments, including operating rooms, hybrid operating rooms, catheter laboratories and intensive care units as well as intra- and inter-hospital patient transportation.

The production is conducted at facilities in Brazil, Dominican Republic, France, Canada, China, Germany, Poland, Sweden, Turkey, the UK and the US. In total, Getinge has over 12.000 employees in more than 41 countries. Getinge's head office is located in Gothenburg, Sweden.

Qualifications:

·         Bachelor degree in Engineering and technical or Health/Life Sciences departments of universities.

·         Preferably  2 to 3  years experience in Regulatory  Affairs  Management in a multinational environment (medical  industry would be an asset).

·         Working knowledge of regulatory registrations in Turkey or other countries.

·         Working knowledge with ISO 13485, MDD (93/42/EEC), FDA requirements and the other global regulations.

·         Knowledge  in MS Office software (Word, Excel, Powerpoint, Outlook), and SAP is required.

·         Excellent command of written & spoken English is compulsory.

·         Team player with excellent communication and presentation skills; able to develop collaborative relationships with various stakeholders both internal and external to achieve objectives.

·         Analytical thinking, result and solution oriented, innovative, proactive, flexible and strong ability on problem solving  and reporting. Must  be able to identify creative options for resolving issues that respond to multiple stakeholder interests and needs,

·         Strong planning, follow up, reporting, coordination and organization skills to achieve accurate and  timely results.

·         No military obligation for male candidates.

·         Be confident, positive, self-motivated& able to work independently

·         Be a good teamplayer

·         Good communication skills

·         Teamwork oriented, ability to establish and maintain effective working relationships\ willing to learn

Job Description

·         Implement  and support registration and re-registration tasks with the authorities.

·         Support the establishment and development of the RA sytem.

·         Responsible for coordination and implementation of RA activities in line with international regulations, Getinge Group policies and procedures.

·         Ensure the completion of regulatory  certification/registration/notification/listing activities in  a correct and  timely manner.

·         Evaluate the effects of change control activities from regulatory perspective and implement required regulatory  steps on a timely manner.

·         Follow the currency and delivery of quality documents and records to the third parties during registration activities.

·         Follow-up of developments and changes in the local & international regulatory policy rules, legislations and guidelines with impact to Getinge activities. Analyze available regulatory and compliance information.