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 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 Interventions (PI) we design, develop, and produce technologies for diagnosing and treating peripheral artery and venous disease. We are able to provide a number of solutions to patients that include: Drug-Eluting Stents, Bare-Metal Stents, Catheters, Balloons, Guide Wires, Atherectomy, Thrombectomy and Intravascular Ultrasound. We have a robust product line and pipeline, and we will continue to make an investment in Peripheral Interventional treatments.
This position can be remote.
The Senior Specialist is responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.
- Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
- 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.
- Develops and implements regulatory strategies for new and modified products.
- 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.
- Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
- 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.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
- Bachelor’s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
- 5+ years related experience, medical industry experience preferred; some regulatory affairs experience required
- Thorough understanding of FDA, European and international regulations
- Strong working knowledge of medical devices, procedures and terminology
- Working knowledge of product development process and design control
- Submission and presentation related computer skills, including experience with software applications such as Microsoft Word, Excel, PowerPoint and Adobe Acrobat
- Ability to effectively manage multiple projects
- Excellent written and oral communication, technical writing and editing skills. Ability to translate technical information into a clearly written message for device reviewers
- Quick learner, self-motivated, independent worker
- Strong technical, research and problem solving skills
- Team player with excellent interpersonal skills
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: 468748