VP, Global Regulatory Affairs JobBoston Scientific Corporation - Marlborough, MA
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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.
About the role:
Everyone in Boston Scientific is working toward one goal -- transforming lives by tackling some of the most important health industry challenges. With innovative products, a collaborative culture and a deep passion for human life, a career with Boston Scientific is more than just a job. It's personal.
By joining Boston Scientific you can help us make a meaningful difference in people's lives. Everyone here has chosen to dedicate their time to impacting the lives of millions of people. This is more than just another job, this is a chance to overcome some of the most important health industry challenges around the world.
The Global Regulatory Affairs VP will provide strategic and technical guidance to influence the regulatory direction of the company. Through: execution of policies impacting patient safety; compliance with pre-market and post-market medical device and combination product regulations and standards; and regulatory agency interactions. In addition, the leader will serve as the global steward of Regulatory Affairs processes, procedures, and tools to facilitate effective execution by the regulatory function across the organization.
Your responsibilities include:
*Responsible for introducing and driving the strategic roadmap for global regulatory while aligning with the company's strategic imperatives. *Leads the collaboration with the divisional and regional regulatory leadership in the creation and maintenance of standards, procedures and consistent tools that improve functional efficiencies and improve functional and cross-functional communications. *Acts as the independent subject matter expert in giving guidance to divisions, while considering companywide implications. Supports and advises divisions on regulatory requirements for acquisition integration and new product development. *Represents the regulatory affairs function through leadership of the Regulatory Affairs Steering Committee, and serving as a member of the Field Action Committee, the Clinical Governance Board and other senior level cross-functional committees, as appropriate. Responsible for regulatory activities in the PIR / Field Action process and the communications to regulatory authorities. *Apprises the Executive Committee of ongoing status of compliance, and making recommendations for areas requiring further attention. *Partners with clinical research to develop the most effective clinical trial strategies and protocols in accordance with regulatory requirements. *Responsible for alignment of global product registrations with global sales and marketing plans. *Represents the Company with outside entities such as regulatory authorities, government entities and industry trade associations. Influencing proposed legislation and regulations, such that they are balanced and fair, and raise issues of concern to the Company *Creates infrastructure to monitor the regulatory process to ensure consistency in submissions, recertification, and other regulatory interactions. *Monitors and provides the divisions & regions with updates on pending changes in global regulations and guidance on how to prepare for the impact on existing business and incorporate the changes into systems. *Provides oversight, and when necessary, assists in the management and timely presentation and submission of IDE's, PMA's, PMA Supplements 510(k)'s, and corresponding international registration packages. *Builds a global regulatory organization that is efficient, effective and meets global strategic needs
*Creates an environment that encourages: constructive feedback and coaching; understanding of individual career goals and aspirations; and proactive developmental support for all employees *Fosters an inclusive workplace that enables all participants to contribute to their full potential in pursuit of organizational and personal objectives.
What we're looking for:
*Bachelor's degree required; Advanced degree preferred
*15 years of direct line Regulatory Affairs experience, with at least 2 years at the Senior Leadership level; global experience preferred *10 years of managerial experience *Experience managing complex matrixed organizational structures and demonstrated capability in collaborating and influencing across such an organization *Expertise in Regulatory pathways including PMA, 510(k), CE Mark, and International registrations *Established relationships with FDA, Competent Authorities and Notified Bodies *Proven experience in successfully guiding complex Regulatory strategies, ensuring effective implementation across the organization
*Demonstrated high degree of integrity, professionalism, and the ability to establish credibility internally and externally
*High sense of urgency and commitment to execution
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
Requisition ID: 355953
17 days 7 hours ago
applyVP, Global Regulatory Affairs Job Boston Scientific Corporation - Marlborough, MA, United States
Our products and technologies are used to diagnose or treat a wide range of medical conditions, including heart, digestive, pulmonary, vascular, urological, women’s health, and chronic pain conditions. We continue to innovate in these areas and are extending our innovations into new geographies and high-growth adjacency markets.
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