Regulatory Affairs Specialist

SIEMENS HEALTHCARE SAĞLIK ANONİM ŞİRKETİ

QUALIFICATIONS AND JOB DESCRIPTION

Do you want to join us in helping to fight the world's most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting?

Then come and join our global team as Regulatory Affairs Specialist tothe Siemens Healthineers Turkey RA organization in implementing and maintaining regulatory compliance in healthcare business.

Your tasks and responsibilities:

·        You will support regulatory activities with the country regulatory affairs team.

·        You will be responsible for the preparation of submission of documents for registration and keep up to date of related registration related documentation.

·        You will be responsible for archiving the electronic and hard copy documents on time and properly.

·        You will update and maintain the product registration database (UTS).

·        You will coordinate the implementation of FSCAs and Field Actions including translations, notification to Authorities, timely distribution of customers letters and achievement of the required response rate.

·        You will ensure compliance with the relevant local and EU directives and related regulations in place.

·        You will support the Quality and RA team for different tasks and projects if needed.

·        You will be supporting local Quality Management System related tasks.

Your qualifications and experience:

·        University degree, preferably in a science-related field or engineering in Biomedical Engineering, Chemical Engineering, or related fields

·        Fresh graduate or max 1-2 years experienced in medical device – IVD regulatory affairs processes

·        Very good command of English

·        Working Knowledge in MS Office Applications

·        No restrictions for travelling

Your attributes and skills:

·        You are result oriented, change oriented and customer focused, team player

·        You have ability to learn new skills and assume new responsibilities,

·        You are strong in data gathering and interpretation

·        You have good planning skills, attention to details and good follow up skills

·        You have Strong communication skills and disciplined working style

Our global team:

We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our culture:

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

Siemens Healthineers stands for a culture of (gender) diversity and inclusion. Therefor we expressively invite women to apply for this position.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. We ask instead that you create a profile in our talent community where you can upload your CV. Setting up a profile lets us know you are interested in career opportunities with us and makes it easy for us to send you an alert when relevant positions become open. 

To all recruitment agencies: Siemens Healthineers does not accept agency resumes. Please do not forward resumes to our jobs alias, employees, or any other company location. Siemens Healthineers is not responsible for any fees related to unsolicited resume