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Specialist II, Peripheral Interventions, Reg Affairs Job at Boston Scientific Corporation

Posted in Compliance 30+ days ago.

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Type: Full Time
Location: Maple Grove, Minnesota

Job Description:

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.

Purpose Statement:

Responsible for Regulatory Affairs support of post market products and projects including regulatory strategy, submissions, change assessment and compliance.

Key Responsibilities:

* 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.

Qualifications:

* 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

About us

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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