Sr. Regulatory Affairs Specialist

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 review
• Research, develop, and implement regulatory strategies for new and modified medical devices
• Represent Regulatory Affairs on development core teams, providing Regulatory feedback and guidance throughout the product development cycle
• Prepare and submit regulatory documentation and applications
• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
• Review and approve product and manufacturing changes for compliance with regulatory requirements
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Continuously assess ways to improve Quality 

What we're looking for in you:

Minimum qualifications: 

• A minimum of a bachelor’s degree in a scientific, technical, or related discipline
• A minimum of 4 years’ in the medical device industry (preferable in regulatory)
• Working knowledge of US, EU, and/or international regulations for medical devices
• General understanding of product development process and design control

Preferred qualifications:

• Understanding of FDA, European, and international regulations.
• General understanding of regulations applicable to the conduct of clinical trial
• Prior experience supporting US and/or international clinical trials 
• Prior experience supporting Systems devices (hardware/software and single use)
• Ability to manage several projects of moderate scope and complexity simultaneously while adhering to time schedules
• Effective research, analytical, and problem-solving skills
• Excellent 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 supervision
• Knowledge of medical devices, procedures, and terminology, including general understanding of cardiovascular diseases and interventional cardiology products
• Team player with excellent interpersonal skills.

Requisition ID: 588506