At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
A Day in the LifeWe are a company inspiring the extraordinary, for more than 70 years, we have led the way with purpose-driven healthcare technology. That history compels us to relentlessly pursue therapies that change lives. The role is opened to continue our daily milestone in serving our patients & partners and give them the highest level of support & partnership which is aligned with our daily mission to alleviate pain, restore health, and extend life.
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.
Responsibilities may include the following and other duties may be assigned:
- 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.
Required Knowledge and Experience:
- 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.
Physical Job Requirements
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.
Benefits & CompensationMedtronic offers a competitive Salary and flexible Benefits Package
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 MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
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.
Learn more about our business, mission, and our commitment to diversity here
