Principal Regulatory Affairs Specialist

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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, this is a place where you can find meaningful purpose, improving lives through your life's work. In the Urology division, we continually advance the quality of patient care with innovative urology solutions.

We have a robust product line and pipeline, and we will continue to make an investment in Urology treatments. This role willbe responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process, as well as developing regulatory strategies and support for new business development efforts associated with external manufacturers (OEM) and contract manufacturers. The role requires strong US, EU, China, and international regulatory experience that can beleveragedto help support international expansion.

The ideal candidate willdemonstrateflexibility in their work schedule to accommodate business needs and collaboration across teams

Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.

Acts as company representative, developing andmaintainingpositive relationships with device reviewers through oral and written communicationsregardingpre-submission strategy/regulatory pathway development, testing requirements,clarificationand follow-up of submissions under review.

Assists with developing and implementing regulatory strategies for new andmodifiedmedical devices, as well as for OEM and Contract Manufacturer partnerships.

Is a liaison for new business partners toprovideregulatory guidance for US, EU, China, and international product registration.

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 recommend appropriate changes.

Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.

Support and maintain

Quality initiatives in accordance withBSCQuality Policy.

Continuously assess ways to improve Quality.

Develops and implements departmental and divisional policies and procedures.

Supports highly technical or major business segment product lines, specialprojectsor strategic initiatives.

A minimum of aBachelor’sdegree in a scientific, technical, or related discipline

A minimum of7years

Regulatory Affairs experience in the medical industry

Prior experience supporting both capital equipment/medical electrical equipment and single-use disposable medical devices.

Prior experience with 510(k) submissions, EUMDRand international regulatory registrations.

Working knowledge of FDA,EUand international regulations for medical devices.

Ability to read and interpret global regulations and standards

General understanding of product development process,designcontroland quality system regulations.

General understanding of regulations applicable to the conduct of clinical…