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Specialist II, Regulatory Affairs Operations - Endoscopy Job

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Date: Aug 31, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations:


Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. Medical Conditions we provide solutions for include: Malignant & Benign Tumors, Gastrointestinal Diseases, Pulmonary Diseases, Gastrointestinal Cancers and Abscesses. We are able to provide a number of solutions to patients that include: Balloon Dilation, Stenting, ERCP/Cholangioscopy, Biliary, Biopsy and Polypectomy, Hemostasis, and Enteral Feeding.  We have a robust product portfolio and pipeline, and Boston Scientific is committed to continued investment in the Endoscopy business. 

The Regulatory Affairs Operations Specialist II will support activities to drive alignment and consistency across the Endoscopy RA Organization, throughout the product lifecycle. Working closely with functional leadership, this position will focus on continuous improvement of Endoscopy RA data, processes, systems, and documents, and support projects to drive standardization and automation.
Your responsibilities include:

  • Support RA systems, processes, and business process to improve the overall effectiveness of the Endoscopy Regulatory Affairs function
  • Maintain regulatory systems to ensure data integrity, resolving data inconsistencies and producing various reports as needed
  • Support efforts to improve collaboration, experience sharing, and best practices within the department and division 
  • Maintain regulated data for Endoscopy using IT systems such as SharePoint, Microsoft Teams, Regis, Windchill, etc.
  • Support regulatory information requests in support of audits, customs, post-market surveillance, government authorities, etc.
  • Provide focused regional support and triage/monitor global registration requests
  • Assist in the creation, maintenance, and tracking of submissions (i.e. 510(k), CE marking applications/change notices, technical documentation, requests for additional information, etc.)
  • Act as a core team member on global project teams, providing Regulatory Affairs feedback and guidance
  • Assist in monitoring and analyzing the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which products are regulated around the world
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy
  • Continuously assess ways to improve Quality 


What we’re looking for:


Required Qualifications:

  • A minimum of a Bachelor’s degree in a scientific, technical, or related discipline
  • A minimum of 2 years experience Regulatory Affairs experience
  • Working knowledge of FDA, EU, and international regulations for medical devices.
  • General understanding of product development process and design control.


Preferred qualifications:

  • Prior experience in the medical device industry
  • Ability to manage several projects
  • High attention to detail, task oriented, deadline conscientious
  • Proficiency in Excel with ability to convert data for more effective analysis
  • Advanced knowledge of Microsoft applications, including creating templates and editing/formatting complex documents in Word, PowerPoint, Visio, & Excel
  • Effective research, analytical, and problem-solving skills
  • Effective written and oral communication, technical writing, and editing skills
  • Ability to work independently within defined parameters. 
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy
  • Establishes and promotes a work environment that supports the Quality Policy and Quality System


Requisition ID: 502280


As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.


So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!


At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.


Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.


Nearest Major Market: Boston

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