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Regulatory Affairs Specialist II - Interventional Cardiology (Hybrid) at Boston Scientific Corporation Malaysia
Maple Grove, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Technical Writing, Editing, Project Management, Interpersonal Skills, Collaboration, Microsoft Word, Microsoft Excel, Microsoft Teams, Microsoft PowerPoint, Adobe Acrobat, FDA Regulations, EU Regulations, Medical Device Regulations, Self-Starter, Fast-Paced Environment, Cross-Functional Teams

Industry

Medical Equipment Manufacturing

Description
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 Level 8 HETAC qualification 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
Responsibilities
Support Regulatory Affairs activities related to Renal Denervation devices within the Interventional Cardiology portfolio. Collaborate on department and divisional process improvements through best practice sharing and cross-functional engagement.