Job Summary

The VP, Quality and Regulatory, has responsibility for ensuring Onkos Surgical's products and Quality Management System (QMS) comply with all appropriate regulations and quality standards required for all regions in which the company desires to conduct business. Lead and develop the Quality and Regulatory teams. Oversee and execute the overall regulatory strategy for realization of new products and product innovation. Implement the overall approach for compliance to current, new and changing regulations/standards. Primary interface with regulatory bodies to support product launches, facility inspections, and external audits. Serves as Management Representative ensuring effective communication of quality, compliance, and regulatory status/needs to management and employees.

Responsibilities

• Lead a team of Quality Managers and Engineers. Responsible for the team’s development and engagement, assessing and managing performance, and driving the team’s progress on key KPIs.
• Oversee the development and implementation of regulatory strategies to efficiently bring products to market (domestic and international).
• Provide advice and guidance regarding the impact of regulatory, quality, and compliance issues on overall corporate strategy and operations.
• Perform the responsibilities of the Management Representative, including the following:

-Ensure that the requirements of the QMS defined by CFR 820, ISO 13485, and other regulatory bodies are effectively established (documented) and maintained.

-Report the effectiveness, performance, and suitability of the QMS to top management (Management with Executive Responsibility) including any need for improvement.

-Promote the awareness of applicable regulatory and QMS requirements and a culture of continual improvement throughout the Onkos organization.

• Develop and enact policies, procedures, and systems to drive continual improvement.
• Monitor, plan, and implement changes to regulatory requirements that impact the Quality Management System and marketed products.
• Act as primary interface during all U.S. FDA, Notified Body, and other inspections/audits.
• Review and approve labelling and promotional material to ensure compliance with all applicable regulatory and QMS requirements.
• Ensure requirements to market product (e.g. - Facility Registration and Listing, UDI, etc.) are fulfilled on an on-going basis

Qualifications/Requirements

• 15+ years of leadership experience in medical device quality and/or regulatory roles
• 1O+ years of experience in Regulatory Affairs/Compliance
• Minimum of BS degree in engineering or scientific discipline, preferably mechanical, biomedical, or other engineering science
• Auditor and regulatory qualifications/certifications a plus
• Demonstrated success related to the implementation and continued effectiveness of quality systems
• In-depth knowledge of current US and international medical device regulations and guidelines
• Experience interacting with FDA and other regulators during inspections, audits, product submissions, and other activities
• Commitment to continual learning and development demonstrated through participation in industry forums, course work, and other learning events
• Excellent interpersonal and leadership skills; self-motivated and flexible to changing schedules
• Strong attention to detail, excellent oral and written communication skills
• Strong computer skills, including word processing, spreadsheet and data programs

About Onkos Surgical

At Onkos Surgical, we believe individuals with cancer requiring surgery deserve solutions designed specifically for them. These individuals, their caregivers and their support network deserve an organization passionately championing their cause. We exist to maintain a singular focus on surgical oncology by looking at everything we do through the lens of the cancer surgeon and their patients. At Onkos Surgical, we will:

• Find solutions to our patients’ unmet clinical needs and advocate for their cause.
• Partner with surgical oncologists through research, education, and innovation, to treat their patients more effectively and more efficiently.
• Collaborate with regulatory agencies to find pathways to provide timely solutions while upholding the highest standards of quality or compliance.
• Fulfill our employees desire to make a difference, in the lives of the patients they serve while achieving their own professional growth.
• Deliver value to our customers and shareholders.