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Sr. Regulatory Document Control Specialist at Boston Scientific Corporation Malaysia

Georgetown, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Document Control, Windchill, SAP, Quality Systems, Continuous Improvement, Customer Service, Problem Solving, Training, Data Management, Change Notices, Regulated Industry, Microsoft Excel, Microsoft Word, Networking, Mentoring, R&D

Industry

Medical Equipment Manufacturing

Description

Exercises judgement within defined procedures and practices to determine and take accurate and timely action to manage and create objects, change notices and change tasks with no guidance of others and/or mentors others in doing so. Explain and apply BSC document and data management tools (Windchill and SAP). Explain and apply concepts from BSC Document Control Policies and Procedures. Interpret and implement Global/Corporate documentation requirements as they relate to local documentation requirements. Demonstrate thorough understanding of document control quality system regulations and standards (Domestic and International) and detailed understanding of applicable internal procedures. Using own initiative, initiate, manage and complete continuous improvement projects ranging form simple to complex. Networking: Represent the department as needed; build relationship with other functional areas and departments; serve as liaison for national and international documentation. Provide training and support for new and/or existing Windchill users. Train new department Documentation Specialists. A minimum high school diploma or equivalent. Minimum of 2-3 years of relevant experience in document control. Strong experience with Windchill and SAP systems. Ability to work independently and support multiple functions (quality, R&D, manufacturing). Proficiency in Microsoft Excel and Word, including running and sorting reports. Customer service skills, including engaging with users and resolving issues. Experience interacting with quality systems or R&D teams. Experience working in a regulated industry. Experience supporting engineers with CMS/change notices. Strong problem-solving skills and ability to mentor or be mentored

Responsibilities

Manage and create objects, change notices, and change tasks independently while mentoring others. Represent the department and provide training and support for document control tools and processes.