Compliance & Regulatory Manager

• Accepting applications for remote US and Canada candidates only

Arterys is one of the market leaders in the space where artificial intelligence meets medical imaging and healthcare. Our platform is transforming medical imaging by moving away from local hospital medical imaging software to cloud AI and web-based medical imaging analytics. Arterys is a venture-backed startup with offices in San Francisco, Calgary, and Paris.

Reporting to the CEO, the Compliance and Regulatory Manager will have primary responsibility for the planning and execution of all medical device, security and privacy compliance strategies. This work involves championing process improvements, completing regulatory submissions, compliance assessments and monitoring, and other medical device and privacy regulatory activities.

This individual will represent Arterys in a positive and professional manner in all interactions with customers, consultants, clinical staff, and all government regulatory agencies. You will be responsible for leading the regulatory strategy implementation, leading the compliance team and partnering with the rest of the organization for cross-functional support. You’ll enjoy being a quality champion and persistently pushing the organization to ‘own’ quality in every function and process. You will also enjoy the fast-paced environment that is our every day at Arterys.

The position requires regulatory and compliance program expertise, in the areas of both medical device and privacy, and change leadership skills as well as passion for innovation and transformation in healthcare.

Essential Duties and Responsibilities:

• Champion process improvement initiatives within the company by working with various teams to identify opportunities.
• Maintain the effectiveness of Arterys Quality Management System (QMS), which includes information security provisions.
• Lead the worldwide regulatory team focused on regulatory strategy, submissions, product registrations, and post-market surveillance for Arterys’s product.
• Challenge the status quo by researching and brainstorming unique solutions to various problems.
• Develop regulatory and compliance strategies while considering business needs and making reasonable trade-offs
• Direct all administrative activities associated with the department, including establishing departmental goals and objectives; preparing and maintaining operating expense and capital budgets; and recruiting, training and assessing key department personnel.
• Collaborate with functional teams to improve documents used/created throughout the software development process and for technical files, design history files, and ongoing product regulatory support. Ensure documentation complies with various standards such as IEC 62304, ISO 13485, ISO 14971, etc, as well as ISO 27001.
• Conduct a Regulatory & Compliance review and approval of software releases. Ensure compliance of labelling and other documents.
• Coordinate and prepare documentation packages for regulatory submissions, including device registrations, company listings, and associated maintenance activities.
• Assist with and ensure Arterys’s compliance to ISO 13485 and applicable medical device regulations and standards; EU GDPR and US HIPAA regulations and privacy standards; and ISO 27001 and applicable information security regulations and standards.
• Develop gap analyses for applicable international guidances and standards. Work with team members to close the gaps.
• Lead and perform internal audits. Manage external audits.
• Assess and coordinate reporting of adverse events, product recalls, and/or privacy breaches to applicable country regulatory authorities.
• Drive the CAPA (corrective and preventive action) process, including root cause analysis, corrective/preventative action implementation, and effective checks.
• Work with various teams to gather, monitor, and analyze data associated with Arterys’s product and procedures. Report this information to the executive.
• Conduct onboarding and training for company personnel on medical device and privacy requirements and applicable procedures. Promote awareness of best practices of a culture of high quality, private, and secure processes and product.

Required Qualifications:

• Experience with maintaining compliance (eg IEC 62304) for a stand-alone software product.
• Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology, biotechnology), engineering, or medical fields; or equivalent experience.
• ISO 13485 internal auditor certificate or equivalent experience
• Ability to interpret international guidelines and regulations, anticipate regulatory concerns, and integrate regulatory requirements into development programs

Preferred Qualifications:

• Over 3 years of experience with leading medical device regulatory and compliance activities.
• In depth knowledge ISO 13485 Medical Device Quality Management System, 21 CFR 820, IEC 62304 and ISO 14971
• General knowledge of security and privacy including EU GDPR, US HIPAA, and ISO 27001.
• Track record of influencing managers and software development teams to adopt quality and “privacy by design” programs and processes.
• Demonstrated success in development and execution of medical device regulatory efforts including writing regulatory submissions (such as US FDA 510k) and the ability to drive submissions with foreign regulatory agencies.
• Excellent project planning, project management, negotiation, and presentation skills.
• Strong problem-solving abilities for handling regulatory processes in the US and globally.

Supervisory Responsibilities:

Regulatory Analysts as needed, compliance and corporate quality personnel & related positions as approved and hired

Authorities for Position:

Perform all the responsibilities while adhering to QMS requirements.

Arterys’ values:

• Honesty: We communicate with candor
• Excellence: We set the bar high
• Accountability: We work together to deliver on commitments
• Respect: We treat others as we want to be treated
• Trust: We are confident in each other’s contributions

Work Environment: Remote, home / office

Location: Remote, US or Canada

Equal Employment Opportunity Statement

Arterys is an Equal Opportunity Employer committed to equal employment opportunity regardless of race, color, ancestry, origin, political affiliation, sex, sexual orientation, gender identity, age, citizenship, marital status, parental status, disability, veteran status or other non-merit factors. Reasonable accommodations may be made to enable individuals with disabilities to perform essential job functions. Pursuant to the San Francisco Fair Chance Ordinance and the Los Angeles Fair Chance Initiative for Hiring, Arterys will consider for employment qualified applicants with arrest and conviction records.

As part of its daily activities, Arterys gathers and uses the personal data of its employees, consultants, and potential employees, such as contact details, qualifications, employment history, and references. The personal data are processed only for the purposes of human resource and product development activities. These are permitted by law in the context of an employment contract, regulatory compliance, or consent. Personal data is disclosed to recipients outside of Arterys, such as management software systems or consultants, for similar purposes. Arterys has implemented appropriate and adequate technical and organizational measures to ensure the security, confidentiality and protection of this personal data. Please ask your Arterys HR representative for more information, such as the Data Privacy Officer contact, international transfers, retention periods, and your rights.