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Regulatory Affairs Specialist II - Interventional Cardiology (Hybrid)

Job Description - Regulatory Affairs Specialist II - Interventional Cardiology (Hybrid)

Your responsibilities will include: Supporting Regulatory Affairs activities related to Renal Denervation devices within the Interventional Cardiology portfolio Supporting department and divisional process improvements through collaboration, best practice sharing, and cross-functional engagement A minimum of a Bachelor's degree in Science, Engineering, or a related discipline Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry Strong technical writing and editing abilities Ability to translate complex technical content for regulatory audiences Proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat Working knowledge of FDA, EU, and international medical device regulations Excellent written and verbal communication skills Strong interpersonal skills and a collaborative team mindset Self-starter with the ability to work independently and adapt quickly in fast-paced environments Proven ability to manage multiple projects and meet deadlines in a dynamic environment Experience collaborating on cross-functional teams
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