Sr. Regulatory Affairs Specialist - Electrophysiology

Additional Location(s):  N/A

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.

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.
 

Your responsibilities will include:

• Develops domestic and international strategies for regulatory approval of company products
• 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, IDEs, 510(k)s, PMA annual reports, and CE Mark submissions under MDR 
• Develops and maintains positive relationships with regulatory body reviewers through oral and written communications 
• 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
• Works with clinical affairs for reporting of A/E's associated with clinical trials

 
Required qualifications:

• Minimum of a bachelor's degree in life sciences, engineering, or related field
• Minimum of 5 years regulatory affairs experience in medical device industry
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations

 
Preferred qualifications:

• Experience with Class II or Class III medical devices submissions
• Experience with capital equipment 
• Experience working directly with FDA, notified bodies and/or international health authorities 
• Strong technical, research, problem-solving, and leadership skills 
• Ability to communicate complex ideas clearly and simply both orally and in writing
• Demonstrated ability to effectively lead multiple projects and priorities
• Team player with excellent interpersonal skills
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat

Requisition ID: 558417

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.