Sr. Regulatory Document Control Specialist

Boston Scientific • Marlborough, MA

54d • $72,800 - $138,300

About The Position

We currently have an open position for a Sr Regulatory Document Control Specialist. This role will be responsible for maintaining and implementing change management systems in support of quality systems and practices to meet BSC, customer and regulatory requirements. The Sr. Regulatory Document Control Specialist serves as a quality representative contact on own area of expertise supporting division requirements.

Requirements

• 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.

Nice To Haves

• Knowledge of Boston Scientific systems and processes.
• Experience supporting engineers with CMS/change notices.
• Strong problem-solving skills and ability to mentor or be mentored

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees