Head of Regulatory Affairs and Quality Assurance

3 weeks ago

Menlo Park CA, United States Russell Solutions Group Full time

Head of Regulatory Affairs and Quality
About This Role:
We are seeking an experienced Head of RA/QA to support U.S. regulatory activities as well as be an individual contributor on regulatory projects. The Head of RA/QA will participate in he planning, development and execution of regulatory submissions. The incumbent will drive all Regulatory Affairs tasks, projects, and operations and oversee all Quality activities. This person is also responsible for ensuring all activities are in compliance with Quality System requirements.
What You Will Do:
Responsible for hiring, managing and prioritizing workload for any regulatory staff. Supervise the Quality Manager and oversee all Quality activities.
Develop and maintain relationships with the Peripheral Vascular staff at the FDA.
Develop and establish strategic regulatory plans and interfaces with project team members, to drive client corporate initiatives to completion.
Assume a leadership role for project management. Works independently to represent regulatory affairs on project teams bringing novel products and manufacturing processes from concept, through development, to market. Ensures product registration requirements are understood by project teams in order to create technical reports during development that will support global registrations.
Review and approves product labeling and marketing materials, including websites and social media. Initiates new package inserts and other required product labeling.
Manage/prepares elements of regulatory submissions (e.g., IDEs, 510(k)s, HDEs, Technical Files and Design Dossiers)
Manage preparation and submission of pre-submission packages, Humanitarian Use Device designation requests and Non-Significant Risk proposals to support regulatory and clinical activities for clients.
Prepare regulatory/clinical strategy packages for executive review, including performing predicate research and relevant literature review from peer-reviewed journals.
Review/participates in preparing design history file documentation, including verification/validation testing, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
Review complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).
Support regulatory field actions.
Qualifications
Required skills:
Director Level: Bachelor’s degree in a technical-related field plus a minimum of 12 years of related work experience, or an equivalent combination of education and experience.
Senior Director/ VP Level: Bachelor’s degree in a technical-related field plus a minimum of 15+ years of related work experience, or an equivalent combination of education and experience.
Experience in overseeing regulatory affairs initiatives and activities with responsibility for the strategic direction of the regulatory affairs function.
Requirements:


Knowledge of FDA’s Quality System Regulation (QSR) and the changing EU Medical Device Regulation (MDR) is required.
High level of professionalism, including strong verbal and written skills, is mandatory.
Strong leadership attributes are necessary. The ability and willingness to prerform activities at various levels, from administrative to strategic
Candidate should possess exceptional project management and technical writing skills.
Preferred:

Peripheral vascular experience highly desired. Relationships in the FDA with the PV regulators would be ideal
Master's degree
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