Posted in Compliance 30+ days ago.
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Type: Full Time
Location: Irvine, California
REGULATORY AFFAIRS OPERATIONS SPECIALIST
Effectively supports Regulatory Affairs compliance processes, process improvement initiatives, and assigned projects supporting global submissions to meet global regulatory requirements, department and company objectives and established timelines. Provides oversight for assigned processes and projects.
* Oversees, updates and maintains assigned Regulatory department procedure documents.
* Understands regulatory processes sufficiently to make recommendations for improvement and develop methods for implementation of improvements.
* Supports global submission preparation as assigned,and performs submission publishing and QC activities.
* Provides support to marketed products as assigned, which may include review and revision of labeling (IFUs, etc.)
* Under supervision of Regulatory management, reviews and approves document change orders (DCOs), manufacturing nonconformance documents, technical documents, test protocols and reports, and other documents.
* Supports development, preparation and submission of high-quality technical information as assigned.
* Under the direction of Regulatory management, develops reports and query responses to global regulatory authorities as assigned.
* Maintains up-to-date knowledge of domestic and international regulatory requirements, and effectively communicates requirements to project teams and management.
* Exercise independent skill and judgment in making day-to-day decisions to accomplish tasks effectively.
* Minimum 2 years relevant medical device work experience
* Minimum bachelor s degree in a scientific discipline or significant relevant work experience.Good interpersonal skills including ability to interact with high degree of diplomacy.
* Solid knowledge of global medical device regulations.
* Comprehensive knowledge of quality systems and relationship to business.
* Complete understanding and wide application of technical or regulatory principles, theories and concepts. General knowledge of other related disciplines.
* Ability to facilitate and provide input when interpreting regulatory standards and guidance s.
* Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
* Must be self-motivated, self-disciplined, and able to prioritize and handle multiple tasks and responsibilities within the internal commitment dates.
* Effective problem-solving techniques.
* Excellent applied thinking and technical writing skills.
* Strong communication and organization skills required.
* Expertise in Microsoft Office applications and charting programs.
Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.