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Specialist II, Regulatory Affairs, Urology & Pelvic Health Job

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Date: Sep 23, 2021

Location: Marlborough, MA, US, 01752

Company: Boston Scientific

Additional Locations: US-MA-Marlborough; US-MN-Arden Hills; US-MN-Minnetonka



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: 
The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders. These conditions account for 50 percent of all urology surgical procedures.  Additionally, we continue to invest in SpaceOAR™ Hydrogel to help minimize the potential side effects of radiation therapy. Come join a growing, global division and become a member of a large and experienced regulatory team! https://www.linkedin.com/showcase/bsc-uroph/

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.
Your responsibilities will include: 
•    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.
•    Develops and implements regulatory strategies for new and modified products.
•    Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions.
•    Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
•    Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
•    Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
•    Trains to departmental and divisional policies and procedures.
•    Fosters a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
•    Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.
Required Qualifications 
•    A minimum of a Bachelor’s degree 
•    A minimum of 3 years experience in Regulatory Affairs in the medical device industry
•    General understanding of product development process and design controls
•    Working knowledge of FDA, EU and international regulations


Preferred Qualifications 
•    Degree in a scientific, technical, or related discipline
•    Prior experience with implantable devices
•    General understanding of regulations applicable to the conduct of clinical trials
•    Ability to manage several projects simultaneously
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    Effective research and analytical skills
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision


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.


Boston Scientific is an Equal Opportunity Employer – Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran


Requisition ID: 500319


Nearest Major Market: Boston

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