Director ARQ AMS Region and Programs

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Job Description

Summary:

The Director Accuray Regulatory & Quality (ARQ) Americas (AMS) Region and Programs is responsible for all global product development programs and quality and regulatory support of the AMS Region business unit for sales and service. The Director serves on the extended leadership team of the commercial AMS Region business for regulatory affairs and driving alignment with corporate quality processes, instilling operational excellence in AMS. The Director manages regulatory support to product development programs, consolidating global regulatory inputs and supporting global submissions with resulting product deliverables. The Director ensures Regulatory Affairs is represented to the global Product Development Teams (PDTs) for Accuray, working cross-functionally to support successful global registrations. This role manages medical device pre-market regulatory registrations and post-marketing reporting for AMS and coordinates global market registrations with the other ARQ Region leaders.

The Director ARQ AMS Region and Programs leads a team of Regulatory and Quality professionals in the AMS Region and to support PDTs. As the most senior Regulatory Affairs leader for the AMS Region, they represent Accuray's products and services to FDA and other AMS medical device regulators, actively engage in regulatory intelligence, and advocating for Accuray's interests with authorities within the Region. The Director leads and develops a team of Regulatory and Quality professionals to accelerate market access for Accuray's products, defining regulatory strategies, executing AMS product submissions and managing a network external consultants and distributors. They collaborate with Quality Assurance, and other ARQ Region managers across the globe to implement best practices and coordinate global strategies to deliver on revenue plans and enable patients to benefit from the latest Accuray products.

Success requires building world-class regulatory intelligence systems to capture market requirements and developing efficient regulatory practices to provide requirements into product development and ensure development efforts produce the evidence required for global registration. This position must be vigilant to monitor developing standards and regulations and assess their impact on Accuray products and regulatory strategy. The Director ARQ AMS Region and Programs provides regular visibility to Regulatory and Quality activities performed in the AMS Region and represents the Region in external audits.

Essential Duties and Responsibilities:

• Represent Accuray Regulatory & Quality on the commercial Region leadership team.
• Champion Quality initiatives and needs for the Region with corporate functions.
• Communicate with business leaders and regulatory team the impact of regulatory developments.
• Manage the development and implement regulatory plans to achieve marketing objectives.
• Ensure Regulatory Affairs represents requirements to programs, and ensure program produces the necessary evidence and deliverables to support the regulatory plan and commercial access.
• Align Region processes with corporate Accuray quality system.
• Provide visibility to Region leadership of operational sales, installation and service activities within the Region, and ongoing Quality initiatives impacting the Region.
• Partner with Regions leadership to ensure regulatory and quality strategies meet revenue plans and objectives.
• Build and execute product and facility submission plans for the Region.
• Lead Regulatory Affairs Program Managers to provide product inputs and ensure product development processes support global registrations.
• Manage regulatory reporting and government correspondence for adverse events and recalls.
• Create and sustain systematic regulatory intelligence and lead processes to translate intelligence into process or product requirements. Build systems to identify relevant evidence, documentation and certification requirements in the Region.
• Lead cross-functional teams in responding to or implementing new regulatory requirements, ensuring that Accuray can succeed through regulatory developments.
• Manage consultants and distributors to develop submission priorities and support product registrations in indirect markets.
• Develop and manage team of regulatory and quality professionals to pursue excellence in quality, regulatory affairs, and regulatory intelligence.
• Engage in regulatory advocacy to support Accuray's positions and strategies and improve patient access to Accuray products and technology.
• Ensure documents and records are filed and maintained to demonstrate compliance to regulatory requirements and preserve organizational knowledge.
• Represent Accuray Regulatory & Quality activities in the Region in external audits.
• Assist as needed in other activities within the ARQ Department.

Qualifications:

a. Required

• Bachelor of Science degree or equivalent in engineering or life sciences or suitable work experience in a technically related field in lieu of formal education.
• At least 10 years of experience in the areas of regulatory affairs, quality systems, process improvement/Lean, or product development/project management.
• At least 5 years of experience with medical device capital equipment or software products.
• Experience with managing complex regulatory or quality documentation for markets such as the: USA, China, Canada, EU, Japan, South Korea.
• Excellent knowledge of process development and continuous process improvement.
• Strong knowledge of worldwide regulatory and quality system requirements.
• Strong team leadership and people development skills.
• Excellent communication, organizational and customer relations skills.
• Ability to travel domestically and internationally up to 10%.
• Fluent in English.

b. Preferred or Desired

• Leadership experience as a member of a leadership team and leading people.
• Experience in project management
• Knowledge and experience in international regulatory affairs.
• Experience in Quality System and Quality Assurance.
• Experience with trade associations in a regulated industry and advocacy.
• Experience with large fixed medical equipment or software, preferably Radiation Therapy or Diagnostic Imaging.
• Advanced technical, regulatory, or legal degree.
• Quality or Regulator Certifications (RAC, ASQ, Six Sigma, etc.)

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To qualify for this position, candidates must be able to furnish proof that they are authorized to work in the country they are applying on a permanent basis without sponsorship.

EEO Statement

At Accuray, our commitment to patient-first outcomes drives an inclusive and collaborative work environment where the best ideas rise to the top - and everyone works to push them further. We value diversity in both the professional and personal backgrounds of our employees, as this variety adds rich energy to every team, every project and every work day. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin - including individuals with disabilities and veterans.

Accuray Pay Transparency Statement:

Accuray pay ranges vary based on work location. As a part of the total compensation package, this role may be eligible for the Accuray Bonus Plan or a role-specific commission/bonus, as well as annual refresh stock grants. Recruiters can share more detail during the hiring process. Each candidate's compensation offer will be based on multiple factors including, but not limited to, geography, experience, skills, future potential and internal pay parity.