Specialist II, Uro/PH, Regulatory Affairs Job
Expiry Date :
Sun, 08 Nov 2020 23:59:59 GMT
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US-MN-Arden Hills; US-MN-Maple Grove
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, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose-improving lives through your life’s 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!
Responsible for Regulatory Affairs support of submissions and on-going regulatory compliance for product development process and sustaining engineering projects.
– 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 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 BSC’s 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.
– Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
– 3+ years of experience in Regulatory Affairs or related discipline (e.g., R & D, Quality, Clinical, Medical Affairs, Biocompatibility) within medical device industry
– Working knowledge of FDA, EU and international medical device regulations
– General understanding of product development process and design controls
– Effective written and oral communication, technical writing and editing skills
– Effective research and analytical skills
– Ability to manage several regulatory projects
– Ability to work independently with minimal supervision
– 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
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 you’re looking to truly make a difference to people both around the world and around the corner, there’s 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