Regulatory Affairs Specialist I

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Minnetonka

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: 
The Regulatory Affairs Specialist I will provide support to the Urology Regulatory Affairs Operations group. Primary responsibilities include support of clinical risk and post market surveillance activities, audits, and Urology Regulatory Affairs Operations strategic initiatives. 

This is a hybrid position (in the office minimum of three days per week) with the flexibility to be located in Marlborough, MA, Minnetonka, MN or Arden Hills, MN. You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Key Responsibilities

• Support development of summary of safety and clinical performance reports (SSCPs), clinical evaluation reports (CERs), post-market clinical follow-up (PMCF), and periodic surveillance update reports (PSURs) in alignment with applicable post market, clinical and regulatory standards and business needs
• Responsible for the preparation and submission of EU Post Market Surveillance submissions to the Notified Body
• Assists in developing and maintaining positive relationships with device reviewers through oral and written communications regarding post market surveillance, pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
• Represent RA on cross functional projects which may include product development, sustaining changes, and continuous improvement efforts
• May assist with reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Support regulatory audits, as required
• Support and maintain Quality initiatives in accordance with BSC Quality Policy
• Continuously assess ways to improve Quality

Required Qualifications

• A minimum of a Bachelor’s Degree 
• A minimum of 2 years' work experience in Regulatory Affairs or a related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
• Prior experience with regulatory submissions writing 
• General understanding of product development process and design controls
• Working knowledge of FDA, EU and/or international regulations
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)

Preferred Qualifications

• Bachelor’s degree in a scientific or technical discipline
• Prior experience with drafting or reviewing SSCP, post market surveillance or clinical risk reports 
• General understanding of regulations applicable to post market surveillance and product development
• Ability to manage several projects simultaneously
• Effective research and analytical skills
• Excellent written and oral communication, technical writing and editing skills
• Ability to work independently with minimal supervision
• Strong interpersonal and influencing skills
   

#LI-Hybrid

Requisition ID: 596932

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’s status, age, mental or physical disability, genetic information or any other protected class.

Boston Scientific maintains a prohibited substance 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.