Boston Scientific Principal Regulatory Affairs Specialist 

United States, Massachusetts, Marlborough 

211989053

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 will be 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 be leveraged to help support international expansion.

This is a hybrid role (in office 3 days per week) based in Marlborough, MA.

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
Assists with developing and implementing regulatory strategies for new and modified medical devices, as well as for OEM and Contract Manufacturer partnerships
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
Support and maintain Quality initiatives in accordance with BSC Quality Policy
Continuously assess ways to improve Quality
Develops and implements departmental and divisional policies and procedures

A minimum of a Bachelor's Degree in a scientific, technical, or related discipline
A minimum of 8 years Regulatory Affairs experience in the medical industry
Prior experience of supporting both the capital equipment as well as single-use disposables
Prior experience with 510(k) submissions, EU MDR and international regulatory registrations
Working knowledge of FDA, EU and international regulations for medical devices
Ability to read and interpret global regulations and standards
General understanding of product development process, design control and quality system regulations
General understanding of regulations applicable to the conduct of clinical trials

Preferred Qualifications:
Prior experience supporting contract manufactured and/or OEM products
Ability to simultaneously manage several projects
Proficiency with Microsoft Office
Effective research and analytical skills
Effective written and oral communication, technical writing and editing skills
Ability to work independently with minimal supervision

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.