Turkey Job Openings
Medtronic
Regulatory Affairs Specialist
Istanbul
FULL TIME
August 30, 2024
In this vital role you will be responsible of managing pre-market activities, driving accountability and operational excellence for execution in compliance with Medtronic standards and national regulatory requirements for TWAL (Türkiye, West Asia, and Levant) region. Please note that this is a project-based position, offered on a fixed-term contract.
- Performs coordination of pre-market activities, such as supporting TWAL region with updating registrations with either MDD extensions, or MDR transitioning (majority in Turkey but also supporting other markets such as Kazakhstan and Pakistan)
- Ensures the compliance of organizations to the related KPIs for pre-market activities.
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits, and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Bachelor’s degree, science background is preferred.
- 2 years of related pre-market regulatory experience, preferably in Medical Devices sector.
- Strong communication skills both verbal and written with different teams.
- Excellent verbal and written English.
- Self-motivated, proactive, dynamic, organized, and decisive.
- Ability to manage multiple priorities and to work with diverse teams & cultures.
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
About Medtronic
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people.
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.
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