Senior Regulatory Affairs Specialist

2 hours ago

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Medtronic

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10,000+

Description

• Plan and execute global regulatory activities for medical device approvals • Ensure compliance with global regulations and Medtronic policies • Partner with Geography RA for international markets • Prepare submissions and negotiate with regulatory agencies • Support post market regulatory compliance activities

Requirements

• Bachelor’s degree required with minimum of 4 years of medical device regulatory affairs experience • OR an advanced degree with 2 years of medical device regulatory affairs experience • Nice to Have US, EU and/or International medical device regulatory submission/approval experience • Knowledge Int’l regulations/requirements • Knowledge/experience with EU MDR implementation • Experience working in a cross-functional team setting • Strong interpersonal and analytical skills • Strong communication skills • Attention to detail • Strong Technical Writing Skills

Benefits

• Competitive Salary and flexible Benefits Package • Recognition for employee contributions • Wide range of benefits and resources • Support for every career and life stage