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Sr. Specialist, Regulatory Affairs - Cardiac Rhythm Management Job

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Date: Nov 20, 2021

Location: Arden Hills, MN, United States, 55112

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. In Rhythm Management (RM) we offer solutions for treating irregular heart rhythms and heart failure, and protecting against sudden cardiac arrest. We continue to innovate in key areas and extending our products into new geographies and high-growth adjacency markets.  

 

Position Summary:

Under minimal supervision, the Senior Regulatory Affairs Specialist is responsible for planning, managing, and implementing regulatory submissions to the US FDA, EU notified body and other country specific regulatory bodies.  The position is also responsible for ensuring continued compliance with regulatory agency approvals including change impact reviews.

 

Position Responsibilities:


•    Develops domestic and international strategies for regulatory approval of company products
•    Coordinates, compiles and submits U.S. and international regulatory filings for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, and other country specific product registrations
•    Develops and maintains positive relationships with regulatory body reviewers through verbal and written communications regarding clarification and follow-up of submissions under review
•    Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
•    Represents RA on cross functional product development, manufacturing and clinical support teams and provide regulatory feedback and guidance throughout the product development cycle
•    Technical and labeling reviews of supporting documents for inclusion in regulatory filings
•    Represents RA on other cross functional projects which may include process changes and continuous improvement efforts.

 

Required Qualifications:


•    A minimum of a Bachelor’s degree in a scientific or technical discipline
•    A minimum of 5 years of experience in regulatory affairs or related discipline (R&D, Quality, Clinical, Medical Affairs, Post Market Surveillance)
•    Demonstrated proficiency with relevant US/International regulatory requirements for medical devices
•    Strong technical, research and problem-solving skills
•    Ability to communicate complex ideas clearly and simply both verbally and in writing
•    Demonstrated ability to effectively manage multiple projects and priorities
•    Team player with excellent interpersonal skills
•    Basic computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 


Preferred Qualifications:


•    Previous experience with Class III medical devices submissions
•    Previous experience working directly with FDA, notified bodies and/or international health authorities
•    Previous regulatory experience with combination products

 

 

 

Requisition ID: 509176

 

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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