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In an environment where medical product regulations seem to be expanding continuously, proportional investment in compliance infrastructure and controls runs the risk of diminishing returns. The key to achieving the right balance of commercial success and compliance is to focus on continuous improvement, specifically root-cause analysis.
The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of medical countermeasures to rare, emerging or serious pathogens.
Medical Device, Quality/Risk Management, Submission & Registration, US Regulatory Affairs
4 Year Degree
Under minimal direction, the Principal Regulatory Affairs Specialist is responsible for planning, managing, composing, and submitting regulatory documentation to the FDA, notified body, and providing information for other country-specific product registrations. The position is also responsible for ensuring continued compliance with regulatory agency approvals.
Develops domestic and international strategies for regulatory approval of company products
Researches and advises company on country-specific international product registration and compliance related requirements
Coordinates, composes, compiles, and submits U.S., E.U. and international regulatory filings for new and modified company products, including 510(k)s, PMA supplements, IDEs, CE Mark technical files & design dossiers and updates, and provides information for other country-specific product registrations
Technical reviews of test protocols and reports and other submission deliverables for inclusion in regulatory filings
Assessment of labeling, advertising, and promotional materials for regulatory compliance and support of claims
Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings
Represents RA on cross functional product development and manufacturing support teams
Works with clinical affairs for reporting of A/E's associated with clinical trials
Assists with customer complaint, MDR, and field action-related tasks as assigned.
Works on and/or leads complex regulatory projects as assigned.
BA/BS Degree in life sciences or engineering or an equivalent (Advanced Degree is a plus)
8+ years regulatory affairs experience
Specific experience in the planning, preparation, and submission of 510(k)s , Technical Files, and Design Dossiers is required. Experience in submitting Q submissions, Pre-IDEs, and IDEs is preferred. Experience in Class III U.S. submissions is a plus.
Demonstrated proficiency with relevant US/International regulatory requirements for medical devices including Quality Systems standards and clinical investigations
Experience working directly with FDA, notified bodies and/or international health authorities is desired
Ability to communicate complex ideas clearly and simply both orally and in writing
Demonstrated ability to effectively manage multiple projects and priorities in a timeline driven environment
Team player with excellent interpersonal skills
Basic submission and presentation related computer skills, including experience with the software applications Microsoft Word, Excel, PowerPoint and Adobe Acrobat
At Boston Scientific, our products and technologies are used to diagnose or treat a wide range of medical conditions. We continue to innovate in key areas and are extending our innovations into new geographies and high-growth adjacency markets. Boston Scientific develops, manufactures, and markets a broad array of products and services that enable less-invasive care for some of the most threateni...ng cardiac conditions. We’ve been expanding indications and conducting pivotal research for nearly 20 years, resulting in increased access to the lifesaving and life-enhancing benefits of ICD and CRT therapies.