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Medtronic is seeking a Regulatory Affairs Specialist for an 18-month contract to manage medical device regulatory submissions, product maintenance, compliance activities, and Health Canada interactions. Candidates need a
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Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to p
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Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to p
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Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95,000 employees work across more than 150 countries to p
Brampton, CAN
Brampton, CAN
Hyderabad, IND
Hyderabad, IND
, IND
, CAN
Riyadh, KSA
, USA
Experience in writing end to end System Engineering requirements and accountability for customer needs alignment.
Experience with Figma & other wireframe tools and ability to produce flow diagrams along with system requirements. Knowledge of IEC 60601-1
Familiarity with Model Based Systems Engineering
Experience with UI design and knowledge of HFE
Experience with medical navigation and imaging capital systems
Knowledge of product security
Experience with product concept development, customer interaction, systems engineering, verification of engineering requirements, and validation of customer needs/design requirements
Working knowledge of systems engineering principles, requirements management, and medical device regulation
Demonstrated strength in written and verbal communication, judgment, decision making, and critical thinking
Demonstrated strength in building strong relationships at all levels of the organization, cross-functionally, and with key people external to the organization
The ideal candidate will possess strong leadership skills and the capability to make trade-offs between risks, benefits, and performance.
Principal Working Relationship : Reports to Associate Director
Experience working with stakeholders from other sites and aligning to changing strategy and business priorities.
Work with Product Manager/Owner/Marketing for churning System Requirements to align the roadmap with strengths and opportunities
Strong oral and written communication skills
Experience in MedTech especially Navigation and Imaging Systems
Familarity with FDA (21CFR 820) & EU MDR Regulation and ISO standards 13485, 62304, 14971
Global leader in medical technology and healthcare solutions.
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