Senior Specialist, Regulatory Affairs (THV)

JENAVALVE TECHNOLOGY INC•Irvine, CA

6d•$95,000 - $95,000•Onsite

About The Position

Responsible for global regulatory affairs communication, regulatory negotiation and correspondence tracking, serious adverse event reporting, post-market surveillance, competitive intelligence, and maintenance of standards program. Under supervision, prepares clinical, pre-market and post-market submissions and query response development and communicates with regulatory authorities and partners. Provides expertise in translating regulatory requirements into practical, workable plans. Provides counsel to project teams as applicable. Ensures timely preparation of organized and scientifically valid submissions. Interacts with internal departments and external representatives (i.e., distributors, legal agents, regulatory agencies).

Requirements

Experience in applying global medical device regulations and product development process
Comprehensive knowledge of quality systems and relationship to business
Ability to interpret regulatory standards and guidance and provide direction to project teams
Ability to work in a fast-paced, technically challenging environment where drive is critical to success.
Self-motivated and self-disciplined; able to prioritize multiple tasks and responsibilities.
Effective interpersonal skills/diplomacy and problem-solving techniques.
Excellent applied thinking and technical writing skills.
Strong communication and organization skills required.
Bachelor’s degree in a scientific discipline or equivalent is required.
Minimum of 3 to 5 years in medical device Regulatory Affairs or other relevant experience.
Works on problems of diverse scope and analyzes data and information to make sound decisions, recommendations, and regulatory filings of high quality.
Exercises good judgment within generally defined practices and policies in all aspects of the job.
Normally receives no instruction on routine work, and general instructions on new assignments.
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, legal documents, or governmental regulations.
Ability to write reports, business correspondence, and procedure manuals.
Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
Ability to work with mathematical concepts such as probability and statistical inference.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Nice To Haves

Experience with US Class III cardiovascular devices preferred.

Responsibilities

Under supervision, lead the preparation, submission, and maintenance of high-quality global filings for investigational device authorizations and registrations, annual reports, and amendments/supplements, communicating with regulatory authorities as applicable.
Serve as the regulatory team member of product development and sustaining teams, providing clear direction and input to assure that applicable global requirements are incorporated in the development process and to drive attainment of company objectives.
Interpret existing or new regulatory requirements as they relate to company products and procedures, labeling, marketing projects, clinical studies, testing, or record keeping.
Manage and oversee submission of serious adverse event reporting, Medical Device Reports (MDRs), Vigilance reports, field safety notices, and other communication with competent authorities and other external stakeholders.
Review and approve FMEAs/risk analyses, protocols, reports, other technical documents.
Review product labeling for compliance with global labeling regulations.
Maintain regulatory intelligence through continuous monitoring of regulatory landscape.
Review and approve document change orders and prepare letters-to-file.
Update departmental procedures as required.
Produce monthly reports on global activities, issues, recommendations, and plans going forward.
Participate in external audits as needed.
Perform other duties as assigned by supervisor.