Director Or Senior Director, Regulatory Affairs

Director or Senior Director, Regulatory Affairs

San Jose, CA, USA Req #183

Monday, March 11, 2024

Veranex is the only truly comprehensive, global, tech-enabled service provider dedicated to the medical technology industry. Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management, market access, regulatory affairs and quality assurance, Veranex enables accelerated speed to market, controlled development costs, development risk mitigation, and accelerated market viability assessment. At every stage, Veranex clients realize efficiencies in cost and time, while our comprehensive solutions unify the entire development process. Veranex partners with the world's most influential life science and medical device companies to research, design, develop and commercialize new healthcare technologies and treatments to advance patient care.

About This Role:

We are seeking an experienced Regulatory Affairs Director or Senior Director to support U.S. and international regulatory activities as well as be an individual contributor on regulatory projects for clients. The Regulatory Affairs Director or Senior Director will participate in the planning, development and execution of regulatory submissions. The Regulatory Affairs Director or Senior Director will act as an advisor to the Regulatory department regarding tasks, projects, and operations. This person is also responsible for ensuring all activities are in compliance with Quality System requirements.

What You Will Do:

• Responsible for managing and prioritizing workload for regulatory staff.
• Develops and establish strategic regulatory plans and interfaces with project team members, both within the organization and with a diverse range of clients, 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 for clients. 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, de novos, PMAs, HDEs, Technical Files, Design Dossiers, and international registrations).
• 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 client design history file documentation, including verification/validation testing, biocompatibility, sterilization, transit and aging documentation, risk management documentation and device draft labeling.
• Review clients complaint files (including submission of MDRs, Vigilance Reports and Mandatory Problem Reports).
• Support regulatory field actions for clients.

Qualifications

Required skills:

Director Level:Bachelor s degree in a technical-related field plus a minimum of 10 years of related work experience, or an equivalent combination of education and experience.

Senior 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.

Experience in overseeing regulatory affairs initiatives and activities with responsibility for the strategic direction of the regulatory affairs function.

Both Director and Senior Director Levels:

• Cardiovascular and Digital Health (SaMD) experience highly desired.
• 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.
• Candidate should possess exceptional project management and technical writing skills.

Preferred:

• Software/Cybersecurity experience

Veranex is an equal opportunity employer and prohibits discrimination of any kind. All qualified applicants will receive consideration for employment without regard for race, color, religion or belief, sex (including pregnancy, gender identity or gender expression), sexual orientation, parental or marital status, disability, age, status as a protected veteran, national, social, or ethnic origin, or any other applicable legally protected characteristics.