Sr Reg Affairs Specialist Job
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PRIMARY LOCATION: US-CA-San Jose
ADDITIONAL LOCATIONS: US-MN-Minnetonka
REQUISITION ID: 283803
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 gynecologic surgical solutions for the treatment of abnormal uterine bleeding and uterine fibroids.
Responsible for Regulatory Affairs support of submissions and on going regulatory compliance for product development process at the Boston Scientific San Jose site.
- 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.
- Bachelor's degree or equivalent work experience, preferably in a scientific or technical discipline
- 5+ years Regulatory Affairs experience, medical device experience required
- PMA submission and combination drug/ device experience preferred
- Working knowledge of FDA and international regulations
- General understanding of product development process and design control
- General understanding of regulations applicable to the conduct of clinical trials
- Working knowledge of regulatory requirements for implantable and single use disposable devices
- Ability to manage several projects
- Proficiency with Microsoft Office
- Effective research and analytical skills
- Effective written and oral communication, technical writing and editing skills
- Ability to work independently with minimal supervision
QUALITY SYSTEM REQUIREMENTS:
- In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
- Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
- Establishes and promotes a work environment that supports the Quality Policy and Quality System.
BOSTON SCIENTIFIC (NYSE: BSX) transforms lives through innovative medical solutions that improve the health of patients around the world. As a global medical technology leader for more than 30 years, we advance science for life by providing a broad range of high performance solutions that address unmet patient needs and reduce the cost of healthcare. For more information, visit us at www.bostonscientific.com.
Boston Scientific is an Equal Opportunity Employer.
Posting Notes: US-CA-San Jose||US-MN-Minnetonka||Regulatory Affairs||(n/a)
Nearest Major Market: San Jose
Nearest Secondary Market: Palo Alto
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