Sr. Regulatory Document Control Specialist

Recruiter: Spencer Gregory Hale

Sr. Regulatory Document Control Specialist

About the Role:

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.

Your Responsibilities Include:

• 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 We’re Looking For

Required Qualifications:

• 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.

Preferred Qualifications:

• 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

Requisition ID: 616309

Minimum Salary: $72800

Maximum Salary: $138300

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.