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Senior Regulatory Affairs Specialist - Urology at Boston Scientific Corporation Malaysia
Irvine, California, United States -
Full Time

Start Date

Immediate

Expiry Date

14 Jan, 26

Salary

0.0

Posted On

16 Oct, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Regulatory Affairs, Medical Devices, Clinical Trials, Product Development, Design Controls, FDA Regulations, EU Regulations, Analytical Skills, Technical Writing, Interpersonal Skills, Microsoft Office, Project Management, Communication Skills, Research Skills, Influencing Skills

Industry

Medical Equipment Manufacturing

Description
A minimum of a Bachelor's degree, preferably in a scientific or technical discipline A minimum of 5 years work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility) Demonstrated experience of the regulatory requirements associated with implantable or active implantable medical devices Prior experience with PMAs for implantable, active implantable medical devices or other Class III Medical Devices Demonstrated experience supporting product development and sustaining activities for implantable or active implantable medical devices Demonstrated experience of regulations applicable to the conduct of clinical trials Prior experience with regulatory submission writing Demonstrated understanding of product development process and design controls Demonstrated knowledge of FDA, EU and/or international regulations Ability to manage several projects simultaneously Effective research and analytical skills Excellent written and oral communication, technical writing and editing skills Ability to work independently with minimal supervision Strong interpersonal and influencing skills Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams, SharePoint, MS Forms)
Responsibilities
The Senior Regulatory Affairs Specialist will support product development and sustaining activities for implantable or active implantable medical devices. This role involves managing regulatory submissions and ensuring compliance with applicable regulations.