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Specialist II, Reg Affairs Job at Boston Scientific Corporation

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Marlborough, Massachusetts

Job Description:

Additional Locations: (n/a)

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.

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 line and pipeline, and we will continue to make an investment in the Endoscopy business.

Job Summary:

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

Key Responsibilities:

*Under minimal 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 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.

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 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.

*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.

Quality System Requirements:

*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.

Boston Scientific (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit us at www.bostonscientific.com.

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: 411554

Nearest Major Market: Boston
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