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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The US Food and Drug Administration (FDA) has published a new draft guidance intended to assist industry with developing products under the agency's so-called "Animal Rule," a regulatory pathway intended to facilitate approvals of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.
AtriCure, Inc. is a medical device company that provides innovative solutions designed to decrease the global Afib epidemic. AtriCure’s Isolator® Synergy™ Ablation System is the first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients undergoing certain open concomitant procedures. AtriCure’s AtriClip® Left Atrial Appendage Management (LAAM) exclusion device is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. AtriCure believes electrophysiologists and cardiothoracic surgeons are adopting its technologies for the treatment of Afib and reduction of Afib related complications. Afib affects more than 33 million people worldwide. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.
The Senior Regulatory Affairs Specialist originates appropriate documents to obtain and maintain marketing privileges consistent with applicable government requirements where AtriCure conducts business. This position will prepare and submit FDA submissions, which may include device 510(k), PMA Supplements, and Design Dossier Amendments to support business growth. The position will serve as regulatory representative on selected projects for new product development or line extension and will provide regulatory supervision on post-market product changes to maintain marketing approvals.
Roles and Responsibilities:
Prepare written regulatory strategies for new product development and sustaining projects
Prepare 510(k) regulatory applications and 510(k) letters to file to secure/maintain marketing approvals
Prepare PMA supplements for device or manufacturing changes
Represent Regulatory Affairs as core team member of new product development projects to drive innovation and to support Design Control process
Provide Regulatory support for risk management activities and clinical evaluation
Develop Regulatory Strategies for new or modified products and assist on project planning
Act as the Regulatory liaison with FDA on behalf of the organization to facilitate timely and favorable review of submissions and pre-submission activity
Collaborate with regional regulatory personnel on assessing and documenting the global impact of product change on product registration and license globally
Assist in development/maintenance of regulatory operational practices
Support inspections by FDA, notified body, and other regulatory agencies
Monitor and provide management with impact of changes in the Regulatory environment
Plans coordinate and compile US regulatory submissions with minimal review and with sign-off responsibility
Demonstrate strong working knowledge of global laws, regulations, guidelines, and standards related to commercialization and post market surveillance
Maintain current knowledge base on existing and emerging regulations, standards, and guidance documents and apply them to change control sign-offs
Independently manage multiple projects, department initiatives, and day-to-day tasks
Demonstrate strong working knowledge of clinical technical concepts and applications related to commercialized products
B.S. or B.A. degree required
A minimum of 5 years of regulatory affairs working experience, mainly for medical devices. Must have knowledge of U.S. and/or European/International regulations and standards
Experience in preparing regulatory submissions; Experience interacting with FDA and/or other regulatory agencies
Must demonstrate good technical writing skill; Must work well in team environments; Must demonstrate good communication skill in team setting
Proficient on programs within Microsoft Office; Proven analytical abilities, Solid understanding of manufacturing and change control, and an awareness of regulatory trends
4 year degree in a technical/scientific discipline
Working experience with FDA pre-submissions and PMA submissions
Experience with medical capital equipment with embedded software and knowledge of electrical device standards, ie. Electrical Safety (IEC 60601-1) and EMC
ESSENTIAL JOB FUNCTIONS (Physical or mental qualification requirement – i.e. walk, sit, stand, bend, push/pull, lift (how much), travel %):
General office work environment
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, age, protected veteran status, status as an individual with disability, sexual orientation or gender identity.
AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions in cardiac tissue for the treatment of atrial fibrillation, or AF, and systems for the exclusion of the left atrial appendage. Cardiothoracic surgeons are adopting AtriCure’s ablation products for the treatment of AF during... concomitant open-heart surgical procedures and sole-therapy minimally invasive procedures. AF affects more than 16 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has not cleared or approved certain AtriCure products for the treatment of AF or a reduction in the risk of stroke.