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Principal Specialist, Regulatory Affairs - Cardiac Rhythm Management Job

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Date: Sep 1, 2021

Location: Arden Hills, MN, US, 55112

Company: Boston Scientific

Additional Locations: (n/a)

 

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.

 

 

About the role:
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.
 
Under minimal supervision, the Principal Regulatory Affairs Specialist is responsible for developing regulatory strategy, planning, managing, and implementing regulatory approvals in the US and EU, as well as supporting world-wide product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
 
Your responsibilities will include:
 
•    Develops domestic and international strategies for regulatory approval of Class I, II and III medical devices
•    Researches and advises company on country specific international product registration and compliance related requirements
•    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 
•    Develops and maintains positive relationships with regulatory agency staff 
•    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, site transfers, and continuous improvement efforts
•    Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact 
•    Review and approval of marketing materials
•    Lead and/or participate in regulatory audits, as required
 
Minimum qualifications:
•    A minimum of a Bachelor's Degree 
•    A minimum of 8 years of regulatory affairs experience in medical device or related industry
•    Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
•    Able to work independently with minimal supervision
•    Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
•    Demonstrated leadership, strategic thinking, project planning, and project management skills
•    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.
•    Strong technical, research and problem-solving skills 
•    Able to work well in fast-paced cross-functional team environments 
•    Ability to articulate complex ideas clearly both verbally and in writing
•    Demonstrated ability to develop strong relationships with regulatory agency staff 
•    Demonstrated ability to effectively lead multiple regulatory projects and priorities
•    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 with Class II or III medical devices submissions
•    Experience working directly with FDA, notified bodies and/or international health authorities

 

 

Requisition ID: 502364

 

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.

 


Nearest Major Market: Minneapolis

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