Boston Scientific Principal Regulatory Affairs Specialist - Endoscopy 

United States, Massachusetts, Marlborough 

905996855

About the role:

At Boston Scientific, this is a place where you can find meaningful purpose, improving lives through your life's work.  In the Endoscopy division, we provide advance technologies for diagnosing and treating diseases of the digestive system, airway and lungs. We have a robust product line and pipeline, and we will continue to make an investment in Endoscopy treatments.  This role in Regulatory Affairs will be responsible for developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion.

Your responsibilities include:

• 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, as well as for OEM and Contract Manufacturer partnerships.

• Is a liaison for new business partners to provide regulatory guidance for US, EU, China, and International product registration.

• 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.

What we're looking for in you:

Required qualifications:

• A minimum of a Bachelor’s degree in a scientific, technical, or related discipline

• A minimum of 8 years Regulatory Affairs experience in the medical industry

• Prior experience with 510K submissions

• Prior experience with Class III devices

• Prior experience with EU MDR.

• Prior experience with China and international regulatory requirements.

• 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.

Preferred qualifications:

• Fluent in Mandarin

• Ability to simultaneously 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.