Boston Scientific
Sr. Regulatory Affairs Specialist
Boston Scientific, Osseo, Minnesota, United States, 55311
Recruiter:
Lydea Monahan
Sr. Regulatory Affairs Specialist
About the role: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 Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.
The Senior Regulatory Affairs Specialist will provide regulatory support on Interventional Cardiology devices and activities which may include new product introduction, evaluation of post market design changes, international submission support, commercial, clinical trial, 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 QualityWhat we're looking for in you:
Minimum qualifications:
A minimum of a bachelor's degree in a scientific, technical, or related disciplineA minimum of 4 years' in the medical device industry (preferable in regulatory)Working knowledge of US, EU, and/or international regulations for medical devicesGeneral understanding of product development process and design controlPreferred qualifications:
Understanding of FDA, European, and international regulations.General understanding of regulations applicable to the conduct of clinical trialPrior experience supporting US and/or international clinical trialsPrior experience supporting Systems devices (hardware/software and single use)Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedulesEffective research, analytical, and problem-solving skillsExcellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators.Basic submission, communication, and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat.Quick learner, self-motivated, and independent worker with minimal supervisionKnowledge of medical devices, procedures, and terminology, including general understanding of cardiovascular diseases and interventional cardiology productsTeam player with excellent interpersonal skills.
Requisition ID:
588506
Lydea Monahan
Sr. Regulatory Affairs Specialist
About the role: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 Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.
The Senior Regulatory Affairs Specialist will provide regulatory support on Interventional Cardiology devices and activities which may include new product introduction, evaluation of post market design changes, international submission support, commercial, clinical trial, 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 QualityWhat we're looking for in you:
Minimum qualifications:
A minimum of a bachelor's degree in a scientific, technical, or related disciplineA minimum of 4 years' in the medical device industry (preferable in regulatory)Working knowledge of US, EU, and/or international regulations for medical devicesGeneral understanding of product development process and design controlPreferred qualifications:
Understanding of FDA, European, and international regulations.General understanding of regulations applicable to the conduct of clinical trialPrior experience supporting US and/or international clinical trialsPrior experience supporting Systems devices (hardware/software and single use)Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedulesEffective research, analytical, and problem-solving skillsExcellent written and oral communication, technical writing, and editing skills. Ability to translate technical information into a clearly written message for regulators.Basic submission, communication, and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, Teams, and PowerPoint and Adobe Acrobat.Quick learner, self-motivated, and independent worker with minimal supervisionKnowledge of medical devices, procedures, and terminology, including general understanding of cardiovascular diseases and interventional cardiology productsTeam player with excellent interpersonal skills.
Requisition ID:
588506