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Regulatory Affairs Specialist

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Date: Jul 2, 2022

Location: Antalya, TR

Company: Getinge

 

 

At Getinge we have the passion to perform

 

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge, our passion is to secure that every person and community have access to the best possible care, offering hospitals and life science institutions products and solutions that aim to improve clinical results and optimize workflows. Every day we collaborate to make a true difference for our customers – and to save more lives.

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

 

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.

 

About us 

Getinge is on an exciting transformation journey constantly looking for new ways to innovate together with our customers to meet the healthcare challenges of the future. We are committed to diversity, equity and inclusion and to sustainability with a goal to be CO2 neutral by 2025. We believe in giving our employees the flexibility they need and make every effort to foster a learning culture that supports their personal development and creativity. Our passionate people hold our brand promise ‘Passion for Life’ close to heart. 

If you share our passion and believe that saving lives is the greatest job in the world, then we look forward to receiving your application and resume. We hope you will join us on our journey to become the world’s most respected and trusted medtech company.