Sr. Regulatory Affairs Specialist - Peripheral Interventions

Additional Location(s): US-MN-Maple Grove; US-CA-Valencia; US-IN-Spencer; US-MA-Marlborough; US-MN-Arden Hills; US-MN-Minneapolis; US-MN-Minnetonka

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance

At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.

About the role:
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.

The Senior Specialist is responsible for Regulatory Affairs support of global regulatory submissions for the BSC product development process, integration of acquired products, and ongoing regulatory compliance.

Your responsibilities will include:

• 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 Integration, manufacturing and/or product 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.

Required qualifications:

• Minimum of a bachelor’s degree, preferably in a scientific or technical discipline. Professional certification(s) preferred
• Minimum of 5 years related experience, medical industry experience preferred; some regulatory affairs experience required

Preferred qualifications:

• 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
• Experience supporting acquired products including integration into new quality system
• 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

Requisition ID: 559661

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!

At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. Boston Scientific is proud to be an equal opportunity and affirmative action employer.

Boston Scientific maintains a drug-free workplace. Pursuant to Va. Code § 2.2-4312 (2000), Boston Scientific is providing notification that the unlawful manufacture, sale, distribution, dispensation, possession, or use of a controlled substance or marijuana is prohibited in the workplace and that violations will result in disciplinary action up to and including termination.

Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.