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Sr. Specialist, Regulatory Affairs - Electrophysiology Job

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Date: Sep 1, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: US-MN-Arden Hills; US-CA-Menlo Park, Remote

 

Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - Caring - 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. 
 
About this role: 
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.
 
Your responsibilities will include: 

•    Supports the development of domestic and international strategies for regulatory approval of Class I, II and III medical devices
•    Coordinates, compiles, and submits U.S. and EU regulatory filings for new and modified products, including PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s, PMA & IDE Annual Reports, and CE Mark submissions under MDR 
•    Supports requests from BSC International Regulatory related to submissions, registrations, and change assessment
•    Develops and maintains positive relationships with regulatory body reviewers 
•    Technical and labeling reviews of supporting documents for inclusion in regulatory filings
•    Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
•    Represents RA on cross functional projects which may include product development, manufacturing process changes, and continuous improvement efforts
•    Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine regulatory impact 
•    Support regulatory audits, as required
 

Required Qualifications
•    A minimum of a Bachelor's Degree 
•    A minimum of 5 years of regulatory affairs or related experience
•    Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
•    Demonstrated experience authoring/supporting a variety of regulatory submissions for US and EU, such as original PMAs, PMA Supplements, pre-submissions, IDEs, 510(k)s and CE Design Dossiers, Tech Files, and MDR Tech Docs.
•    Demonstrated ability to effectively manage multiple regulatory projects and priorities
•    Strong technical, research and problem-solving skills
•    Ability to articulate complex ideas clearly both verbally and in writing
•    Demonstrated ability to effectively manage multiple projects and priorities
•    Works well in fast-paced cross-functional team environments 
•    Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

 

Preferred Qualifications
•    Bachelor's Degree in life sciences, engineering, or related field
•    Previous experience in the medical device industry with Class II or III device submissions
•    Experience working directly with FDA, notified bodies and/or international health authorities 

 

 

Requisition ID: 502399

 

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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