Regulatory Affairs Manager

Ümraniye, İstanbul
Sürekli
Tam zamanlı

9 gün önce

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 Life Come and join our regional Regulatory Affairs Team as Regulatory Affairs Manager to oversee both pre-market and post-market regulatory activities in Levant, Gulf and Pakistan countries (Cyprus, Iran, Iraq, Jordan, Lebanon, Syria, Bahrain, Kuwait, Oman, Qatar, Yemen, UAE, Pakistan and Afghanistan) and work with a talented team.The role is crucial to enable timely product launches and business continuity in the said regions by sustaining strong relations with distributors, authorities as well as internal stakeholders including country leaders. The role will report into Sr. Regulatory Affairs Manager responsible for Turkiye, West Asia, Levant and Gulf.Responsibilities may include the following and other duties may be assigned:

Drives an effective product planning & submission process across region with proactive alignment with relevant stakeholders
Leads to compile all materials required in submissions, license renewal and annual registrations
Recommends changes for labelling, manufacturing, marketing for regulatory compliance
Ensure audit readiness in organization and continue meeting our Quality KPIs
Ensures effective monitoring, communication and collaboration on new & changing regulations and required actions
Executes a comprehensive Q/RA advocacy strategy and may direct interaction with regulatory agencies on defined matters. Active participation in related Trade Associations
Recommends strategies for earliest possible approvals of product dossiers in specified regions and drive optimization and foster innovation in regulatory processes
Foster and contribute to the culture of Engagement, Inclusion and Innovation as a people manager.

Required Knowledge and Experience:

Bachelor’s degree or equivalent
Minimum 5 years of experience in the regulatory affairs
Strong leadership skills including proven minimum 1 year of people management
Ability to influence to authorities and stakeholders & strong presentation skills
Strong communication skills
Proven success stories in Regulatory Affairs & Quality Assurance
Medical device experience and knowledge in those countries are preferred
Strong adoption skills and ability of multi-tasking
Strong follow-up skills with being result-oriented
Excellent fluency in English both written and verbal.

Physical Job RequirementsThe 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 95,000+ 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

Medtronic

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