Sr. Regulatory Affairs Specialist - Endoscopy

Work mode:  Hybrid
Onsite Location(s): 

Marlborough, MA, US, 01752

Additional Location(s):  N/A

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - 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:
Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work.  In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs.  Our robust product portfolio provides a variety of solutions including but not limited to balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, radio frequency ablation, and enteral feeding.  We continue to innovate and make investments in Endoscopy treatments, both within established product lines as well as in future pipelines.

 

The Senior Regulatory Affairs Specialist will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.

 

Your responsibilities will include:

  • Act as company representative under minimal supervision, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, and submission review
  • Research, develop, and implement regulatory strategies for new and modified medical devices
  • Represent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cycle
  • Prepare and submit regulatory documentation and applications
  • Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
  • Review and approve product and manufacturing changes for compliance with regulatory requirements
  • Support and maintain Quality initiatives in accordance with BSC Quality Policy
  • Continuously assess ways to improve Quality

 

Required qualifications:

  • A minimum of a bachelor’s degree in a scientific, technical, or related discipline
  • A minimum of 5 years’ Regulatory Affairs, or related experience (Quality, Clinical, R&D, Biocompatibility, etc.), within the medical device, pharmaceutical, or health care industry
  • Working knowledge of US, EU, and/or international regulations for medical devices
  • General understanding of product development process and design control

 

Preferred qualifications:

  • General understanding of regulations applicable to the conduct of clinical trial
  • Ability to manage several projects of moderate scope and complexity simultaneously
  • Proficiency with Microsoft Office
  • Effective research, analytical, and problem-solving skills
  • Effective written and oral communication, technical writing, and editing skills
  • Ability to work independently with minimal supervision
     

Requisition ID: 574702


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 prohibited substance 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.

 

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status.  Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment.  Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements.   As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.


Nearest Major Market: Boston

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