Principal Regulatory Affairs Specialist

Additional Location(s): N/A

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 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.

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

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

Is a liaison for new business partners to provide regulatory 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 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

Supports highly technical or major business segment product lines, special projects or strategic initiatives

Required Qualifications:

A minimum of a Bachelor's Degree in a scientific, technical, or related discipline

A minimum of 8years Regulatory Affairsexperience 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

#LI-Hybrid

Requisition ID:593123

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran's status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance freeworkplace. 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.