Job Description

Additional Locations: (n/a); US-MA-Marlborough

Purpose and Passion Comprehensive Benefits Life-Work Integration Community Career Growth

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, were solving some of the most important healthcare industry challenges. Together, were one global team committed to making a difference in peoples lives around the world. This is a place where you can find a career with meaningful purposeimproving lives through your lifes work.

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! https://www.linkedin.com/showcase/bsc-uroph/

Job Purpose:

Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for MDR, product development process and sustaining engineering projects.

Key Responsibilities:

* 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.
* Responsible for management, maintenance, coordination and updates with EU Notified Bodies related to Uro/PH MDR certificate management; including Class III, IIb implantable and lower classification certificates.
* Responsible for preparation and submission of global regulatory applications, EU Post Market Surveillance Reporting submissions, SSCP, as well as internal regulatory file documentation.
* Reviews and collaborates with design, clinical, and manufacturing teams on responses to questions from EU regulatory bodies related to compliance to the EU Medical Device Regulation.
* Develops and implements regulatory strategies for projects that cross across UroPH franchises, such as manufacturing site transfers or regulation changes.
* Acts as a core member providing regulatory feedback and guidance throughout the product and manufacturing process development cycle and coordinating team inputs for submissions.
* Reviews and approves design and manufacturing changes for cross franchise programs, ensuring compliance with applicable regulations.
* Trains to departmental and divisional policies and procedures.
* Fosters a work environment of continuous improvement in support of BSCs Quality Policy, Quality System and the appropriate regulations for their area of responsibility.
* Supports efforts to improve collaboration, knowledge sharing, and best practices within the department and division.

Key Qualifications:

* Bachelors degree or equivalent work experience, preferably in a scientific or technical discipline
* Professional certification(s) and/or Masters degree preferred
* 8+ years Medical Device Regulatory Affairs experience, or 5+ years Medical Device Regulatory Affairs experience and 3+ years of experience in a related discipline (e.g., R&D, Quality, Clinical, Medical Affairs, Biocompatibility) within medical device industry
* Submission experience including Design Dossier and Tech File reviews with Notified Bodies, PMA/510(k) and international
* Thorough understanding of US, EU and international medical device regulations
* Thorough understanding of product development process and design controls

Other Qualifications:

* Effective written and oral communication, technical writing and editing skills
* Excellent research and analytical skills
* Ability to manage several regulatory projects
* Ability to work independently with minimal supervision
* Strong technical knowledge of medical devices, procedures, practices, and related terminology
Proficiency with Microsoft Office applications (Word, Excel, PowerPoint)
* General understanding of regulations applicable to conduct of clinical trials
* General understanding of standards applicable to medical devices
* Prior experience working with Notified Bodies on substantial changes, and management of Design Dossier renewals preferred

About us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If youre looking to truly make a difference to people both around the world and around the corner, theres no better place to make it happen.

Boston Scientific is an Equal Opportunity Employer Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Disability, Veteran

Requisition ID: 476450