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Specialist II, Regulatory Affairs - Peripheral Intervention Job

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Date: Nov 22, 2021

Location: Maple Grove, MN, United States, 55311

Company: Boston Scientific

Additional Locations:


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.



At Boston Scientific, you’ll discover a place where you can have meaningful purpose, improving lives through your life's work. Over 200M patients around the world suffer from Peripheral Arterial Disease (PAD) with less than 1% receiving an intervention. Boston Scientific’s Peripheral Interventions division has built a strong portfolio of products to serve this market and are uniquely positioned to provide physicians and hospital systems with a full toolbox of solutions to treat patients. Come join a growing, global division and become a member of a large and experienced regulatory team!  



About this role: 

With adequate supervision, the Regulatory Affairs Specialist II is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified bodies, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.


Your responsibilities will include: 

•    Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
•    Acts as a core team member on new product development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for global submissions.
•    Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
•    Responsible for preparation and submission of US and EU regulatory applications, as well as internal regulatory file documentation.
•    Acts as primary liaison with US FDA and EU notified bodies for submissions under review.
•    Supports international geographies to gain and maintain product approvals.
•    Trains to departmental and divisional policies and procedures.
•    Fosters a work environment of continuous improvement in relation to BSC’s Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
•    Supports efforts to continuously improve department and divisional quality, including collaboration, best practices, and knowledge sharing.


What we’re looking for in you: 

Required Qualifications :

•    A minimum of a Bachelor’s degree
•    A minimum of 3 years Regulatory Affairs or a related discipline (such as R&D, Quality, Clinical, Biocompatibility, Labeling, etc.) in medical devices or pharmaceutical industry 
•    General understanding of product development process and design controls
•    Working knowledge of FDA, EU and international regulations
•    Ability to manage several projects simultaneously
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams)
•    Effective research and analytical skills
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision


Preferred Qualifications:

•    Previous experience with Class II or III medical devices submissions is desired
•    Experience working directly with FDA, notified bodies and/or international health authorities is desired
•    Ability to speak Spanish




Requisition ID: 512862


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.


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