Regulatory Affairs Specialist II - Neuromodulation

Additional Location(s): US-IN-Spencer; US-GA-Alpharetta; US-MN-Arden Hills; US-MN-Maple Grove; US-RI-Coventry

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:
Support the regulatory submission activities to obtain and maintain approvals for conducting clinical investigations and for commercially distributing products worldwide. Participate in activities to ensure compliance with worldwide regulatory requirements.

This is a hybrid position (in office minimum three days per week) with a preferred location in Valencia, CA with flexibility to be located in other US BSC locations.  You will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Your responsibilities include:

• Support the preparation of submissions (i.e. PMA, PMA supplements, CE marking applications, etc.) to obtain various worldwide approvals to commercially distribute products
• In conjunction with Clinical Research, support the preparation of applications (i.e., IDE, IDE supplements, Investigator Brochure) for conducting clinical investigations in U.S., Canada, Australia and EU countries
• Prepare required submissions (progress reports, etc.) to facilitate the continuation of clinical studies
• Participate in the review and submission activities (annual reports, change notifications, etc.) to support the maintenance of marketing approvals.
• Support product registrations for international markets as required
• Participate in project development teams and review plans, reports, risk management and design reviews associated with product and process projects
• Other duties as assigned

Required qualifications:

• A minimum of a bachelor’s degree and 1-3 years’ work experience in regulatory affairs  
• Prior experience with class III Medical Devices
• Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards

Preferred qualifications:

• Effective written and oral communication, technical writing and editing skills 
• Interpersonal, communication and negotiating skills
• Works well in fast-paced cross-functional team environments
• RA certification (by Regulatory Affairs Professional Society)

The anticipated annualized base pay range this full-time position working at this location will be from [$69,000 to $112,750], plus variable compensation, i.e., annual bonus target (subject to plan eligibility and other requirements) and the value of core and optional employee benefits being offered at Boston Scientific (BSC), which can be reviewed at www.bscbenefitsconnect.com.  At BSC, it is not typical for an individual to be hired near the bottom or top of the pay range. BSC considers various factors in determining actual compensation for this position at the expected location.  Actual compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, and other relevant business or organizational needs.  Actual compensation may be otherwise adjusted if the position is filled outside of the intended geographic location.

#LI-Hybrid

RSRBSC

Requisition ID: 586292

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.