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Specialist I Regulatory Affairs - Endoscopy Job

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Date: Sep 26, 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.

 

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 strategy, submissions, and on-going regulatory compliance throughout the product lifecycle.


Responsibilities:

  • Under supervision, acts 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 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 assesses product and manufacturing changes for compliance with applicable regulations 
  • Collaboration with international regulatory counterparts to ensure compliance to local regulations when developing regulatory strategies and assessing changes
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy.
  • Continuously assess ways to improve Quality.

 

What we're looking for:

 

Basic Qualifications

  • Bachelor’s degree in a scientific, technical or related discipline
  • A minimum of One (1) year Regulatory Affairs or related experience.
  • Medical Device industry experience highly preferred
  • General knowledge of current and proposed EU regulations for medical devices
  • Familiar with ISO 13485 and MDSAP requirements
  • General knowledge of product development process and design control
  • Ability to manage several projects simultaneously
  • 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
  • Good interpersonal skills
  • Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy

 

Requisition ID: 492096

 

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

Job Segment: Gastroenterology, Regulatory Affairs, Medical, Law, Product Development, Healthcare, Legal, Research