Posted in Compliance 30+ days ago.
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Type: Full Time
Location: ARDEN HILLS, 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.
The individual will be responsible for helping to set direction for Boston Scientific around the coordination and implementation of programs that are required by government agencies, and providing consultation on corporate-wide regulatory requirements and compliance activities. The individual will be a key resource for global regulatory activities.
* Provide regulatory representation on corporate-wide digital health projects related to product development, design controls, design assurance and sustaining engineering.
* Provide expertise and guidance in interpreting regulations and agency guidelines, specifically in the area of software and digital health.
* Facilitate cross-divisional and cross-geography forums
* Provide Regulatory support for process improvements
* Act as a Regulatory liaison
* Support activities and projects related to BSC Digital Health and Global Healthcare Solutions.
* Monitor and analyze the impact of emerging or revised laws, regulations, enforcement actions and other changes that impact the manner by which Boston Scientific products are regulated around the world.
* Provide, as needed, regulatory strategic support and direction to corporate-wide programs and initiatives.
* Develop and maintain company Standard Operating Procedures (SOPs) intended to assure compliance with applicable global regulatory requirements.
* Provide technical content and direction to the development of regulatory training modules.
* Provide regulatory training to cross functional groups.
* May represent Regulatory Affairs at management updates.
* Provide Corporate technical guidance during the course of strategy formulation and interaction with regulatory bodies.
* Investigate, provide solutions and verify effectiveness on related regulatory compliance programs (e.g., CAPAs, audit findings).
* May serve as liaison to and attend meetings of, medical device industry trade associations (e.g., AdvaMed, MDMA).
* Lead corporate projects and projects designed to improve the effectiveness of the Regulatory Affairs function.
* Build Quality into all aspects of job performance by maintaining compliance to all quality requirements.
* Bachelor s degree or equivalent work experience, preferably in a scientific or technical discipline
* Professional certification(s) preferred
* 8+ years Regulatory Affairs medical industry experience
* Demonstrated success in management of regulatory submissions activities
* Thorough understanding of global regulations
* Strong technical knowledge of medical products, software experience preferred
* Strong technical understanding of relevant procedures, practices, and associated medical terminology
* Strong knowledge of clinical trial strategy and study design, and sponsor reporting requirements
* Thorough knowledge of product development process and design control
* Excellent research and analytical skills
* Ability to manage multiple projects
* Excellent written and oral communication, technical writing and editing skills
* Strong leadership, interpersonal and influencing skills
* Proficiency with Microsoft Office
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: 410953
Nearest Major Market: Minneapolis
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