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Specialist II, Endoscopy, Regulatory Affairs Job

Remote Eligible: 
Onsite Locations(s): 

Marlborough, MA, US, 01752

Additional Locations: 

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Additional Locations:

 

 

Purpose and Passion • Comprehensive Benefits • Life-Work Integration • Community • Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose—improving lives through your life’s work.

 

 

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. Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.

 

Your responsibilities include:

  • Act as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Assists with developing and implementing regulatory strategies for new and modified medical devices
  • Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product and manufacturing process development cycle.
  • Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes.
  • Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  • Continuously assess ways to improve Quality.
  • Supports efforts to improve collaboration, experience sharing and best practices within the department and division.

 

What we’re looking for:

Basic Qualifications:

  • Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline.
  • 2 + years Regulatory Affairs or related experience, medical industry experience preferred.
  • Working knowledge of FDA, EU and international regulations for medical devices.
  • General understanding of product development process and design control.
  • General understanding of regulations applicable to the conduct of clinical trials.

Preferred qualifications:

  • Ability to manage several projects.
  • Proficiency with Microsoft Office.
  • Effective research and analytical skills.
  • Effective written and oral communication, technical writing and editing skills.
  • Ability to work independently with minimal supervision. 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.

 

 

 

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

 

Requisition ID: 481067

 


Nearest Major Market: Boston

Job Segment: Gastroenterology, Medical, Regulatory Affairs, Engineer, Law, Healthcare, Legal, Engineering

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