What you will do:

• Work with the SVP Regulatory Compliance, Development, implementation, maintenance and overall success of the company’s regulatory affairs and quality assurance strategy & programs; including establishing quality standards/metrics/objectives, developing methods to embed quality into the product development and manufacturing process, establishing supplier relationships and quality standards and developing and implementing innovative programs to focus employees on improving product quality.
• Implement process improvements required to ensure GxP compliance in early clinical development environment with strategic view to grow Quality function as the products advance to late-stage development and commercialization. Building and managing relationships with FDA and global regulatory agencies and standards groups. Defining and implementing regulatory strategies and submissions in support of new and existing products as relevant.
• Develop and maintain current regulatory knowledge and staying abreast of regulatory procedures and changes, interpreting regulations, providing regulatory insight, advice and support to other functions. Coordinates internal and external quality audits and preparation of audit reports, corrective action plans and follow up updates.
• Ensure adequacy of departmental and company standard operating procedures (SOPs) from a GxP perspective. Oversee global regulatory strategy and submissions in compliance with all applicable global regulatory requirements and in alignment with corporate goals.
• Serve as the company representative for the FDA and other relevant external stakeholders, including Twist Biopharmaceutical partnerships. Ensure supplier quality objectives are met Provide strategic and technical leadership of Quality Assurance activities and deliverables in support of the product pipelines.
• Collaborate with senior management and all functional groups at all levels of the enterprise to drive a culture of Quality. Implement, monitor, and promote best practices of Quality Management Systems to ensure compliance with relevant FDA, EU, and global regulations/directives/requirements Identify, resolve, or escalate any and all product, process or customer Quality-related issues that pose risk with respect to the patient, customers or compliance. Develop and manage department and study-specific budgets.  Initial focus will be on Quality Assurance with a transition to Regulatory Affairs.


Quality Management System (QMS) Leadership:
• Monitor, implement changes, and maintain the organization’s QMS to meet quality objectives and requirements worldwide.
• Establish and monitor key performance indicators (KPIs) to measure the effectiveness of the QMS.
• Manage the core quality system activities and deliverables to maintain compliance to international medical device regulations and certifications.
• Formulate, write and maintain procedures, specifications and standards for the quality control of ISV products to ISO 13485, MDR and 21 CFR 820.
• Maintain training system records and processes for the QMS required training.
• Maintain supplier management records and files.
• Provide guidance to employees on quality system quality regulation requirements.
• Maintain the defect management records and processes.
• This is a hands on role.


Regulatory Compliance:
• Stay current with relevant industry regulations and standards.
• Ensure the organization’s compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.
• Be willing to learn/expand in the regulatory affairs focus area


Quality Assurance Strategy:
• Stay current with relevant industry regulations and standards.
• Ensure the organization’s compliance with applicable regulatory requirements, such as FDA, ISO, or other industry-specific standards.


Team Management:
• Recruit, train, and mentor a high-performing team of quality professionals.
• Set performance expectations, conduct regular performance reviews, and promote professional development.


Quality Control:
• Implement effective quality control processes and methodologies to monitor product or service quality.
• Lead investigations and root cause analyses for quality issues and implement corrective and preventive actions (CAPAs).


Process Improvement:
• Continuously assess and improve quality-related processes and procedures.
• Collaborate with cross-functional teams to optimize workflows and enhance product or service quality.


Documentation and Reporting:
• Maintain accurate and comprehensive quality documentation, including records of audits, inspections, and quality reports.
• Prepare and present quality-related reports to senior management.

What you bring:

• Bachelor’s degree in relevant area of engineering or scientific discipline.  Advanced degree (MS or PhD) is strongly preferred. At least 15+ years of progressive related experience leading RA/QA in a life sciences company - primary focus on QA with progressive learning in RA.  Experience with in SaMD, SaaS, SWMD models and software focused quality systems.
• The VP RA/QA will be analytical, results and process oriented by nature, detail driven, possesses strong interpersonal skills, and have a desire and passion for quality and regulatory compliance.
• Excellent working knowledge of the US and global regulatory framework and their relevant governing authorities with direct experience handling submissions [e.g., PMA, 510(k), CE Marking].
• Direct experience with FDA Quality System Regulations and ISO 13485 regulatory requirements and implementation.
• Extensive experience in preparing and leading engagements directly with regulatory agencies. Ability to coach others to do the same.
• A commercial focus in the application of regulatory requirements.
• Outstanding communication skills, both verbal and written, and the ability to interface effectively across key functional areas.
• Strong conceptual, analytical, and problem-solving abilities.
• Excellent time management and organizational skills and demonstrated ability to manage and prioritize multiple teams, multiple projects, and meet deadlines.
• Proven experience in leading change management initiatives through periods of rapid expansion.
• Working knowledge of multiple business functions, including operations, quality, logistics, finance, sales, customer service, engineering, IT, and human resources.
• Ability to travel based on business needs, typically 10-20%, but flexing higher when needed.

What we offer you:

• RapidAI pays 100% for employee coverage & 75% for your dependent coverage for medical, dental & vision premiums.
• Medical Benefits – We offer a range of policies through TriNet 
• Life Insurance/AD&D is 1X times your annual salary
• We pay 100% for Short and Long Term Disability.
• Healthcare and Dependent care flexible spending accounts are available
• A 401k plan is offered through Empower
• RapidAI provides $100 a month for internet/cell/phone services.
Time Off:
• We have 10 company paid holidays!
• RapidAI has a flexible vacation policy.  We urge employees to take vacation! Vacation allows employees to renew, reinvigorate, and rejuvenate.
Other Cool Benefits:
• Equity - Stock Options
• Incentive Compensation
• And most importantly - You are joining an awesome team!