Principal Regulatory Affairs Specialist - Electrophysiology

Additional Location(s): US-MN-Arden Hills

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 this role:
This role will be responsible for working on Boston Scientific’s novel Atrial Fibrillation technology, the FARAPULSE Pulsed Field Ablation (PFA) System. The FARAPULSE PFA System was the first PFA technology that received a CE Mark in Europe and gained PMA approval in the US early last year. PFA technology is transforming ablation therapy on a global scale, and Boston Scientific is investing in portfolio development, robust clinical evidence, and global execution as we expand the capabilities and reach of this product with different indications.

This is a hybrid role (in office 3 days per week) based in Arden Hills, Minnesota.  
 
Your responsibilities will include:

• Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams
• Represents Regulatory Affairs on cross functional projects which may include new product development, manufacturing process changes, site transfers, and continuous improvement efforts
• Develops domestic and international strategies for regulatory approval of Class II and III electronic medical equipment devices
• Coordinates, compiles, and submits US 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 international regulatory partners with investigational device and commercial marketing applications
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
• Technical and labeling reviews of supporting documents for inclusion in regulatory filings
• Review of clinical study protocols and other clinical documentation, and assessment of clinical study related changes to determine the regulatory impact
• Develops and maintains positive relationships with regulatory agency staff
• Lead and/or participate in regulatory audits, as required

Required Qualifications:

• Minimum of a Bachelor's Degree
• Minimum of 7 years of Regulatory Affairs experience in the medical device industry, or 5 years’ experience with an advanced degree (Master’s or PhD)
• Demonstrated proficiency with relevant US/EU regulatory requirements for medical devices including Quality Systems standards and clinical investigations
• Solid understanding and knowledge of product development process, clinical development, manufacturing, and change control
• 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
• 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 scientific, technical, or related discipline
• Experience working directly with FDA, notified bodies and/or international health authorities
• Prior experience with electrophysiology and/or medical electronic equipment products
• Able to work independently with minimal supervision
• Demonstrated leadership, strategic thinking, project planning, and project management 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
• Prior experience providing technical guidance, training, and/or mentoring to Regulatory Affairs and/or cross-functional peers
   

Requisition ID: 602277

Minimum Salary: $99100 

Maximum Salary: $188300 

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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 Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identify, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class.

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.