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Sr. Specialist, Regulatory Affairs - Urology Job

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): 

Marlborough, MA, US, 01752

Additional Location(s): US-MA-Marlborough; US-MN-Arden Hills; US-MN-Maple Grove; 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.



UroPH Regulatory Affairs: Senior Specialist, Labeling, eLabeling, and Advertising and Promotional Materials


The Urology and Pelvic Health business unit provides proven, leading solutions to treat five common urology diseases, including kidney stones, benign prostatic hyperplasia (BPH), erectile dysfunction (ED), male incontinence and pelvic floor disorders. These conditions account for 50 percent of all urology surgical procedures.  Additionally, we continue to invest in SpaceOAR™ Hydrogel to help minimize the potential side effects of radiation therapy. Come join a growing, global division and become a member of a large and experienced regulatory team!


Your responsibilities will include:

•    Reviews, comments and approves internally and externally facing advertising, sales support and promotional material for medical devices, including but not limited to implantable devices, single use devices, and capital equipment.
•    Ensures marketing materials consistency with cleared or approved labeling in the US and EU.
•    Partners with Marketing team on upcoming campaign strategies and events,  and ensures regulatory requirements will be met.
•    Reviews and signs-off on all internal/external advertising/promotional pieces in online review tool ensuring compliance with applicable regulations.
•    Provides labeling/eLabeling regulatory guidance to cross-functional and corporate teams.
•    Develops and implements regulatory strategies for division-wide device labeling/eLabeling changes.
•    Acts as a core member on project teams, providing regulatory feedback and guidance throughout the program, and coordinating team inputs.
•    Provides data and information to other functions on processes and procedures, as requested.
•    Uses online review tool software for functional area to compile and generate reports, statistics, timelines, tables, graphs, correspondence and presentations.
•    May write and implement processes/procedures to enhance workflow and knowledge of cross-functional partners.
•    Provides data and information to others on functional unit processes and procedures.
•    May assist with special projects.



What we’re looking for in you:


Required Qualifications:

•    A minimum of a Bachelor’s degree or equivalent combination of education and experience
•    A minimum of 5 years’ experience in Regulatory Affairs or related discipline (i.e., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) in the medical device, pharmaceutical, or health care industry
•    General understanding of product development process documents, international standards and urology disease state products
•    Ability to manage several projects simultaneously
•    Effective research and analytical skills
•    Effective written and oral communication, technical acumen and editing skills
•    Ability to work independently with minimal supervision
•    Proficiency with Microsoft Office


Preferred Qualifications:

•    Degree in a scientific or technical discipline
•    Skilled in Microsoft Excel to create formulas, v look ups, pivot tables and work with multiple worksheets in Excel; using captions, cross references and inserting graphics, charts and tables in Word; creating forms, queries and reports in Access




Requisition ID: 535114


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: Boston

Job Segment: Regulatory Affairs, Medical Device, Compliance, Pharmaceutical, Urology, Legal, Healthcare, Science

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