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Specialist II, Reg Affairs

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Remote in Country
Onsite Location(s): 

Valencia, CA, US, 91355

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:


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.


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.



What we’re looking for:



Required Qualifications


•    A minimum of a Bachelor's Degree or equivalent work experience
•    A minimum of 3 years work experience in regulatory affairs or related discipline in medical devices (R&D, Quality, Clinical, Medical Affairs, Biocompatibility)
•    Prior experience with class III Medical Devices
•    Knowledge and experience with U.S. FDA, Canada, EU, and/or international regulations and standards.
•    Effective written and oral communication, technical writing and editing skills 
•    Works well in fast-paced cross-functional team environments



Preferred Qualifications:

•    Minimum of 7 years experience with Post Market Assessment
•    Interpersonal, communication and negotiating skills.
•    RA certification (by Regulatory Affairs Professional Society)




Requisition ID: 532537


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.

Nearest Major Market: Los Angeles

Job Segment: Clinical Research, Medical Research, Compliance, Regulatory Affairs, Technical Writer, Healthcare, Legal, Technology

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