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Principal Specialist, Regulatory Affairs - Urology & Pelvic Health 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.



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.  Come join a growing, global division and become a member of a large and experienced regulatory team!


Job Purpose:

Responsible for Regulatory Affairs support of submissions and ongoing regulatory compliance for product development process and sustaining engineering projects.



Key Responsibilities:

•    Supports highly technical or major business segment product lines, sterilization processes, special projects, or strategic initiatives.
•    Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
•    Acts as a core member on new product development teams, providing regulatory feedback and guidance throughout the product and manufacturing process development cycle, and coordinating team inputs for submissions.
•    Develops and implements regulatory strategies for new and modified products.
•    Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
•    Acts as company representative, developing and maintaining positive relationships with regulators (i.e., device reviewers) through oral and written communications pertaining to pre-submissions, development of regulatory pathway and testing requirements, and handling of additional information requests and interactive reviews in support of submissions under review.
•    Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
•    Reviews and approves device labeling and advertising materials for compliance with global regulations; analyzes content and recommends changes if warranted.
•    Trains to departmental and divisional policies and procedures.
•    Leads efforts to improve collaboration, knowledge sharing, and best practices within the department and division.
•    Assesses regulatory processes and proposes and implements new or improved departmental policies and procedures.
•    Fosters a work environment of continuous improvement in support of BSC’s Quality Policy, Quality System, and the applicable regulations for their area of responsibility.


Required Qualifications:

•    A minimum of a Bachelor’s degree or equivalent work experience
•    A minimum of 7 years’ experience in Medical Device Regulatory Affairs, or a minimum of 5 years’ experience in Medical Device Regulatory Affairs plus a minimum of 2 years’ experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) within the medical device, pharmaceutical, or health care industries
•    Experience with patient-contacting medical devices
•    Experience with US regulatory submissions for medical devices [510(k) and/or PMA]
•    Thorough understanding of US, EU and/or international medical device regulations 
•    Thorough understanding of medical device development process and design controls


Preferred Qualifications:

•    Degree in a scientific or technical discipline
•    Demonstrated excellent written and oral communication, technical writing and editing skills
•    Excellent research and analytical skills
•    Strong leadership, interpersonal and influencing skills
•    Demonstrated ability to manage multiple regulatory projects simultaneously, as well as serve as regulatory lead on projects
•    Ability to work independently with minimal supervision, as well as mentor/guide others
•    Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
•    Solid understanding of Program Management principles
•    Strong technical knowledge of medical devices, procedures, practices, and related terminology
•    Proficient understanding of regulations applicable to conduct of clinical trials
•    Experience with EU MDD/MDR regulatory submissions
•    Experience with medical electrical equipment (i.e., software-controlled devices)
•    Comprehensive understanding of medical device standards, in particular ISO 13485, ISO 14971, IEC 62366, and preferably IEC 60601-series and IEC 62304




Requisition ID: 537468


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

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