Recruiter:Spencer Gregory HaleSr. Regulatory Affairs Specialist – EndoscopyAbout 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 reviewResearch, develop, and implement regulatory strategies for new and modified medical devicesRepresent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cyclePrepare and submit regulatory documentation and applicationsReview device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changesReview and approve product and manufacturing changes for compliance with regulatory requirementsSupport and maintain Quality initiatives in accordance with BSC Quality PolicyContinuously assess ways to improve QualityRequired qualifications:A minimum of a bachelor's degree in a scientific, technical, or related disciplineA minimum of 5 years' Regulatory Affairs, or related experience (Quality, Clinical, R&D, Biocompatibility, etc.), within the medical device, pharmaceutical, or health care industryWorking knowledge of US, EU, and/or international regulations for medical devicesGeneral understanding of product development process and design controlPreferred qualifications:General understanding of regulations applicable to the conduct of clinical trialAbility to manage several projects of moderate scope and complexity simultaneouslyProficiency with Microsoft OfficeEffective research, analytical, and problem-solving skillsEffective written and oral communication, technical writing, and editing skillsAbility to work independently with minimal supervisionRequisition ID: 582426Among other requirements, Boston Scientific maintains specific prohibited substancetest requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to aprohibited substancetest as a requirement. The goal of theprohibited substancetesting is to increase workplace safety in compliance with the applicable law.
