regulatory affairs specialist

şimdi başvur

iş ilanı detay

istanbul, ıstanbul (anadolu)
referans numarası

iş tanımı

We are looking for a "Regulatory Affairs Specialist" for our global client operating in medical devices industry.

Maintain a system to receive product registration requests, prepare product registrations and follow up on post submission activities.
Review registrations requests received from SBUs/ RCOs for completeness and provide feedback on completeness of requests.
Prioritize registration requests and communicate to stakeholders.
Prepare regulatory submissions.
Provide any additional information required by coordinating with the SBU.
Build intelligence in terms of efforts, cost and time required to register the products by country and product type.
Update applicable tracking systems to provide real time update on status of registration requests and re-registrations.
Track re-registration requirements and submit as necessary.
Maintain a database that provides registration requirements based on country and product type.
Update the database as regulatory requirements change.
Document the company experience of registering certain SBU’s products.
Review labeling for compliance with requirements in the applicable country.
Review applicable translations for appropriateness of claims and compliance with requirements.
Ensure local distribution centers comply with company and local requirements.
Ensure general warehousing controls are in place at the local distribution centers.
Support and advocate the delivery of the organisations’ mission, goals and values.


Bachelor’s degree or equivalent in science or engineering.
Experience in quality/regulatory in life sciences, preferably in medical devices.
Significant experience interacting with international regulatoryagencies for product registrations.
Ability to work effectively through influence and relationship building.
Knowledge of ISO 9001 or 13485 quality management system.
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