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 Interventional Cardiology (IC) we design, develop, and produce technologies for diagnosing and treating coronary artery disease and other cardiovascular disorders. Medical Conditions we provide solutions for include: Cardiovascular Diseases, Coronary Artery Disease, Acute Myocardial Infarction. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Coronary Atherectomy and Coronary Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Interventional treatments.
Responsible for regulatory submissions supporting NPD, clinical trials and sustaining projects and on-going regulatory compliance activities for post market reporting/agency interaction.
Your responsibilities will include:
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
- Specific experience in strategic planning, preparation, and submission of PMA, IDE, Technical Files, and Design Dossiers is required. Experience in software and hardware submission is preferred. Experience in Class II U.S. is a plus.
- Experience working directly with FDA is required.
- Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
- Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
- Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment.
- Team player with excellent interpersonal skills.
- Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
- Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
- Develops and implements departmental and divisional policies and procedures.
- Supports highly technical or major business segment product lines, special projects or strategic initiatives.
- A minimum of a bachelor’s degree in a scientific, technical, or related discipline.
- A minimum of 7 years experience Regulatory Affairs in the medical industry.
- Ability to travel at least 10%.
- Professional certification(s), such as RAC, is preferred.
- Excellent research and analytical skills.
- Ability to manage multiple projects.
- Demonstrated success in management of regulatory submissions activities.
- Thorough understanding of global regulations.
- Strong technical knowledge of medical products.
- Strong technical understanding of relevant procedures, practices, and associated medical terminology.
- Thorough understanding of clinical trial strategy and study design, and sponsor reporting requirements.
- Thorough knowledge of product development process and design control.
- Excellent written and oral communication, technical writing and editing skills.
- Strong leadership, interpersonal and influencing skills.
- Proficiency with Microsoft Office.