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Sr. Specialist, Regulatory Affairs - Peripheral Interventions Job

Remote Eligible:  Remote in Country
Onsite Locations(s): 

Maple Grove, MN, US

Additional Locations:  N/A

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

 

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!  

 

 

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 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.

 

 

Position Responsibilities:


•    Develops domestic and international strategies for regulatory approval of class II and III medical devices
•    Coordinates, compiles and submits U.S. and EU regulatory applications for new and modified products, including PMAs, 510(k)s, IDEs, CE Marking submissions, as well as internal regulatory file documentation.
•    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.
•    Supports international geographies to gain and maintain product approvals.
•    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.
 

 

Required Qualifications:


•    A minimum of a Bachelor’s degree
•    A minimum of 5 years experience in Regulatory Affairs or related discipline in medical devices (R&D, Quality, Clinical, Biocompatibility, Labeling)
•    Demonstrated proficiency with relevant US/EU/International regulatory requirements for class II or III medical devices including Quality System standards and clinical investigations
•    General understanding of product development process and design controls
•    Effective written and oral communication, technical writing and editing skills
•    Ability to work independently with minimal supervision
•    Demonstrated ability to effectively manage multiple projects and priorities
•    Team player with excellent interpersonal skills
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Teams)

 

Preferred Qualifications:


•    Previous experience writing 510k or PMA submissions
•    Previous experience working directly with FDA, notified bodies and/or international health authorities
•    Spanish language skills beneficial, not required

 


 

 

Requisition ID: 517429

 

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.

 

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.


Nearest Major Market: Minneapolis

Job Segment: Medical, Regulatory Affairs, Product Development, Law, Compliance, Healthcare, Legal, Research

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