Prin Reg Affairs Specialist Job
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POST DATE 9/20/2017
END DATE 12/23/2017
Boston Scientific Corporation
JOB DESCRIPTIONAdditional Locations: (n/a)
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.
At Boston Scientific, you ll discover a place where you can find meaningful purpose, improving lives through your life's work. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. This position is in the American Medical Systems (AMS) business of Boston Scientific includes Men s Health and Prostate Health for treatment of urologic conditions, including benign prostatic hyperplasia (BPH), male stress urinary incontinence and erectile dysfunction.
About the role:
Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process.
Your responsibilities include:
* Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and cross-functional teams.
* 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.
* Develops and implements regulatory strategies for new and modified products.
* Acts as a core member on manufacturing and development teams, providing regulatory feedback and guidance throughout the product development cycle, and coordinating team inputs for submissions.
* Responsible for preparation and submission of global regulatory applications, as well as internal regulatory file documentation.
* Reviews device labeling and advertising materials for compliance with global regulations; analyzes and recommends appropriate changes.
* Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
* Develops and implements departmental and divisional policies and procedures.
* Supports highly technical or major business segment product lines, special projects or strategic initiatives.
* Establish and support a work environment of continuous improvement that supports BSC s Quality Policy, Quality System and the appropriate regulations for the area they support. Ensure employees are trained to do their work and their training is documented.
What we re looking for:
* Bachelor s degree or equivalent work experience required, preferably in a scientific or technical discipline
* 8+ years Regulatory Affairs experience, medical device experience required
* PMA submission and combination drug/ device experience preferred
* Experience with lasers and fibers preferred
* Working knowledge of FDA and international regulations required
* General understanding of product development process and design control required
* General understanding of regulations applicable to the conduct of clinical trials required
* Working knowledge of regulatory requirements for implantable and single use disposable devices preferred
* Ability to manage several projects required
* Proficiency with Microsoft Office required
* Effective research and analytical skills required
* Effective written and oral communication, technical writing and editing skills required
* Ability to work independently with minimal supervision
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
Requisition ID: 367053
Nearest Major Market: Minneapolis
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