This position is under minimal supervision of the Associate Director Regulatory Affairs
- Manage activities and projects concerned with the submission and approval of products to government regulatory agencies to ensure compliance with regulations.
- Develop world-wide regulatory strategies (with minimal supervision) to ensure rapid and timely approval of devices and continued regulatory support of marketed devices and other products.
- Provides guidance to project team members regarding regulatory and compliance issues by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
- Prepares and maintains regulatory submissions and files including but not limited to 510(k)'s, IDE/IDE Supplements, PMA/PMA Supplements, Annual Reports, Design Dossiers/Change Notifications, and Technical Files for a diverse range of neurosurgical products, including Class III devices.
- Prepares necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.
- Interacts with regulatory agency personnel in order to expedite approval of pending applications and to resolve regulatory matters.
- Review and approve proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations.
- Represent Regulatory Affairs on cross-functional project teams
- Bachelor degree with 7-9 years of experience or PhD, PharmD, MS with equivalent experience
- Excellent written, verbal communication and presentation skills.
- Experience in the preparation and submission of US and EU regulatory filings, including Class III devices.
- Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.
- Consults with others to understand the benefits and risks associated with decision alternatives before making decisions.
- Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
- Practical experience in a medical device Regulatory environment, preparing submissions for Class II and Class III medical devices (US and EU).