Principal Regulatory Affairs Specialist - Global Strategy & Advocacy

September 15

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Description

• Lead global regulatory strategies for diabetes devices • Collaborate cross-functionally to advance new product technologies • Develop and refine regulatory strategies with international teams • Manage projects for business improvement initiatives • Provide strategic input for submission packages • Maintain good relationships with regulatory agencies and partners

Requirements

• Bachelor's degree and a minimum of 7 years of regulatory experience in medical device, biotech, or pharmaceutical industries • Or, advanced degree with a minimum of 5 years of regulatory experience in the same fields • Master’s Degree or Doctorate in scientific/engineering fields preferred • Critical thinking and creative problem solving skills • Technically savvy in engineering disciplines • Clear communication skills for various stakeholders • Ability to analyze data and provide recommendations • Experience with regulatory submissions and agency requirements

Benefits

• Competitive Salary • Flexible Benefits Package • Opportunity to participate in a short-term incentive program • Commitment to employee contributions

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