Date: Sep 25, 2018
Location:Arden Hills, MN, US, 55112
Company: Boston Scientific
Additional Locations: US-MA-Marlborough
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 purposeimproving lives through your life's work.
About the role:
The Director, Corporate Regulatory Affairs will provide strategic and technical guidance to influence the regulatory direction of the company. Primary responsibilities for this role include the identification, development, and implementation of strategic initiatives and franchise structure.
Your Responsibilities Include:
Directs and coordinates the Regulatory Affairs department and related global submission activities.
Establishes departmental priorities to meet business objectives.
Ensures that effective regulatory strategies are developed and implemented for new and modified devices to assure timely approval/market clearance/registrations, in support of corporate goals and objectives.
Ensures compliance with all relevant regulations and guidelines.
Assures consistency and quality of submissions, through technical guidance to team during the course of strategy formulation and submission preparation.
Manages relationships with local regulatory agencies and notified bodies.
Support and maintain Quality initiatives in accordance with BSC Quality Policy.
Partners with Clinical Research to develop the most effective clinical trial strategies and protocols.
Advises divisional management team of prevailing and evolving global regulatory requirements and environment.
Develops, implements, and maintains departmental policies and procedures.
Provides regulatory guidance to divisional MDR reporting function.
Develops and manages departmental budget.
Provides support to corporate regulatory device listing and establishment registration documentation as appropriate.
Coordinates post-market approval activities.
Fosters employee career development.
Participates in trade and professional organizations.
Provides Regulatory Affairs training to manufacturing and development teams.
Provides regulatory support in new business development activities.
Fosters relationships with business partners to ensure regulatory compliance.
What We're Looking For:
Bachelors of Engineering, Science or technical degree and related development and design experience in the medical device with a minimum of 12 years in FDA regulated industry (or equivalent combination of experience and education)
Minimum 10 years people management experience
Ability to interact with senior leadership across the organization
Must have demonstrated leadership, coaching, employee development, influencing, and negotiation skills
Demonstrated presentation and facilitation skills required
Proven history of driving process improvements. Process excellence experience and experience leading change management projects. Experience with Lean Business Process (LBP methodology) is advantageous
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: 436820
Nearest Major Market: Minneapolis
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