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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.

Boston Scientific is a place where you can find meaningful purpose, improving lives through your life's work. In the Endoscopy division, we provide advanced technologies for diagnosing and treating diseases of the digestive system, airway, and lungs. Our robust product portfolio provides a variety of solutions including but not limited to balloon dilation, stenting, ERCP/cholangioscopy, biliary, biopsy and polypectomy, hemostasis, endobariatric solutions, radiofrequency ablation, and enteral feeding. We continue to innovate and make investments in Endoscopy treatments, both within established product lines as well as in future pipelines.

About the role:

The Regulatory Affairs Specialist III will provide regulatory support on a range of Endoscopy devices and activities which include new product introduction, evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.

At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week.

Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time.

Your responsibilities will include:

Develops and implements regulatory strategies for new and modified medical devices
Acts as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle
Supports the coordination, drafting, and submitting of U.S. and EU regulatory filings for new and modified medical devices
Reviews device labeling and advertising materials for compliance with submissions and applicable regulations; analyzes and recommends appropriate changes
Reviews change notifications and performs regulatory impact assessments for product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings, and supports associated global submissions
Supports technical or major business segment product lines, special projects or strategic initiatives
Acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review
Supports and maintains Quality initiatives in accordance with BSC Quality Policy
Continuously assess ways to improve Quality

Required qualifications:

Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
3+ years relevant work experience, including experience with Regulatory Affairs in the medical device industry
Working knowledge of FDA, EU MDR, and international regulations for medical devices
General understanding of product development process and design control
General understanding of regulations applicable to the conduct of clinical trials
Ability to simultaneously manage several projects

Preferred qualifications:

Prior experience working on submissions such as 510(k)s, PMAs, IDEs, EU MDR, or international regulatory registrations
Proficiency with Microsoft Office
Effective research, analytical, and problem-solving skills
Effective written and oral communication, technical writing, and editing skills
Ability to work independently with minimal supervision

#LI-Hybrid

Requisition ID: 611453

Minimum Salary: $79700

Maximum Salary: $151400

The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see www.bscbenefitsconnect.com--will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above.

Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements).

Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).

For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability.

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

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.

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