Regulatory Affairs Specialist III

Additional Location(s): US-MN-Maple Grove

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 career with meaningful purpose, improving lives through your life’s work. We offer a collaborative culture that values diversity and prioritizes initiatives that promote awareness and inclusion, celebrating personal, cultural, and demographic differences of our customers, patients, and workforce. 

We are looking to hire an enthusiastic individual for a Regulatory Affairs Specialist III position (hybrid work mode) supporting our rapidly growing Left Atrial Appendage Closure (LAAC) device portfolio:

https://www.bostonscientific.com/en-US/products/laac-system.html

In this role, you’ll be part of a high-functioning, close-knit Regulatory Affairs team responsible for support of submissions and on-going regulatory compliance through partnership with our global R&D, manufacturing, clinical, and quality teams.
  
Your responsibilities will include: 
Reviews change notifications and performs regulatory impact assessment for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions as needed  
Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified Class II and Class III products   
Supports clinical activities as needed, including post-approval study and IDE annual reporting
Provides technical reviews of test protocols and reports  
Assesses labeling materials, including Instructions for Use  
Represents RA on cross functional project teams 
Participates in corporate and departmental training  
Works as liaison with International BSC Regulatory colleagues on various projects, including providing support with international regulatory filings 

Required qualifications: 

• Bachelor’s Degree
• Minimum of 3 years of experience in Regulatory Affairs or a related discipline within medical devices (such as R&D, Quality, Clinical, Biocompatibility, or Labeling), including at least 2 years specifically in a Regulatory Affairs role
• Knowledge of US and EU medical device classification and submission pathways 
• Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat 

Preferred qualifications:

• Previous experience with Class II and III medical devices change assessments and submissions
• Ability to communicate complex ideas clearly and concisely (both verbally and in writing)
• Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment 
• Experience working directly with FDA, notified bodies and/or international health authorities 
• BA/BS Degree in life sciences, engineering or an equivalent 
   

#LI-Hybrid

Requisition ID: 602242

Minimum Salary: $76000 

Maximum Salary: $144400 

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.