Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Maple Grove, Minnesota
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 Peripheral Intervention (PI), we develop and market devices to less-invasively treat vascular system blockages in areas such as the carotid and renal arteries and the lower extremities and cancer. Medical Conditions we provide solutions for include: Peripheral Artery Disease (PAD), Deep Vein Thrombosis (DVT), Critical Limb Ischemia (CLI), and Liver Cancer. The solutions for these conditions include all classifications of devices: Peripheral Balloons and Stents, Drug-Eluting Technologies, Thrombectomy Systems, Atherectomy Devices, Wires, Drainage and Coils and Spherical Embolics. We have a robust product line and pipeline, and we will continue to make an investment in Peripheral Interventional treatments.
Responsible for Regulatory Affairs support of post market products and projects including regulatory strategy, submissions, change assessment and compliance.
* Acts as a core team member on sustaining, providing regulatory feedback and guidance throughout the product development cycle.
* Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation.
* Implements regulatory strategies for new and modified medical devices.
* Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
* Begins to act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding clarification and follow-up of submissions under review.
* Assists with departmental policy and procedure implementation.
* Assists with Regulatory Affairs training to cross functional groups.
* Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes.
* Bachelor s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
* 2+ years related experience, medical industry experience preferred
* Understanding of FDA, European and international regulations
* Knowledge of medical devices, procedures and terminology
* Working knowledge of product development process and design control
* Basic submission and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat
* Ability to manage multiple projects
* Excellent written and oral communication, technical writing and editing skills. Ability to translate technical information into a clearly written message for the regulators
* Quick learner, self-motivated, independent worker
* Strong technical, research and problem solving skills
* Team player with excellent interpersonal skills
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: 430584
Nearest Major Market: Minneapolis
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