regulatory affairs specialist

yayınlanma
şimdi başvur

iş ilanı detay

yayınlanma
lokasyon
antalya
sektör
Mühendislik
referans numarası
6446

iş tanımı

We are looking for a "Regulatory Affairs Specialist" for one of our global customer who operates in the medical sector.

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

Follow-up of developments and changes in the local international standartds, regulatory rules, legislations and guidelines.

Plays active role in implementation of Regulations/Guidance Documents throughout the functions and participate in standards assessment process with responsible parties at site.

Plays an active role in Notified Body, FDA and other authorities audits and represents regulatory topics.

Plays role in resolution of regulatory relevant Quality Plans, CAPA, nonconformity or other QMS activities.

Plays an active role in managing and maintaining of Regulatory Holds and concessions.

Play an active role in Engineering and R&D activities.

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

Contribute to all the product and quality certification related processes and all internal activities (e.g. CHMM, new product phases/launches) from RA perspective.

Implement and support registration and re-registration tasks with the authorities for new products or changes in existing products.

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

nitelikler

Bachelor degree in Chemistry, Biology, Biotechnical, Engineering or related technical disciplines.

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

Working knowledge of product registrations worldwide.

Working knowledge with ISO 13485, MDD (93/42/EEC), MDR and 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 communication and presentation skills; able to develop collaborative relationships with various stakeholders both

internal and external to achieve objectives.

Analytical thinking.

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

Be confident, positive, self-motivated able to work independently.
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