Director of Quality and Regulatory Affairs

San Francisco Bay Area /
G&A – Regulatory and Reimbursement /
Full-Time
About Us: Artera is a biotech startup that develops medical artificial intelligence tests that personalize therapy for cancer patients. Artera is on a mission to personalize medical decisions for patients and physicians on a global scale.

Director, Quality and Regulatory Affairs is responsible for helping to shape, execute, and support the Artera Quality and Regulatory Strategy for its medical devices, defining and understanding emerging trends and challenges and the organization’s readiness to address them.
The Director is responsible for supporting the development and improvement of the regulatory quality capabilities at Artera and enhancing and supporting the continuing improvement of performance. This position is also accountable and responsible for developing and ensuring an effective implementation of the company’s escalation process in the presence in alignment with the overall compliance and quality strategy. Additionally, the Director is responsible for supporting the programs and activities necessary to address organizational quality and compliance gaps, inspection readiness and new requirements to support ongoing compliance are implemented in an efficient, professional, measurable and effective manner.

The Director will help drive proactive compliance and quality engagement within the organization.

Essential Responsibilities:

    • Acts as the process owner for escalation of compliance or quality concerns and establishes and maintains written policies and procedures accordingly. Works with internal stakeholders and company leadership on strategies for both improvement and efficiency
    • Provides analysis on quality and compliance matters involving the design, development, manufacture and distribution of software as a medical device and in vitro diagnostics products
    • Maintains comprehensive knowledge of applicable regulatory requirements and their interpretation inclusive of the monitoring and sharing of external Q&R compliance insights across BD
    • Supports development and monitoring of regulatory audit/inspection metrics at Artera
    • Keeps management apprised of quality metrics, and any concerns regarding quality or compliance pertaining to regulatory activities.
    • Provides leadership and guidance on issues associated with audit findings and compliance risk
    • Partners with stakeholders to develop strategies and tools to ensure External Audit readiness and management across the organization provides strategic support to the businesses and regions where needed
    • Supports strategic initiatives that target continuous improvement and achievement of compliance excellence through engagement in external audit programs (MDSAP, VIP MDDAP)
    • Supports the development and review of external Health Authority and notified body observation responses (appropriate response, investigation, corrective actions, timing, execution), complaints, and appeals
    • Collaborates with IT Teams to implement and maintain technology system solutions for Quality Audits across BD and a business SME
    • Understands impact on patient and customer, generates ideas, and embraces change

Fiscal Responsibilities

    • Helps develop and monitors department and project budgets
    • Provides justification for resource requirements to senior management

Education and Experience Requirements:

    • Minimum BA/BS degree or equivalent in a Life Science, Engineering, or Physical Science with an advanced technical degree or MBA preferred
    • Minimum of 5 years of experience in quality management with at least 2 years experience in an FDA regulated environment and managing a compliance/audit function
    • Experience with or knowledge of FDA Quality System Management, ISO 13485, ISO 14971. Experience with CLIA laboratory quality management in addition to medical device quality management is a plus

Knowledge, Skills and Abilities:

    • Knowledge of and experienced in all regulatory compliance aspects of the business: pre-market, commercial, post-market, and regulatory.
    • Demonstrated comprehensive expertise in the applied interpretation of the US & worldwide regulatory standards and laws applicable to the medical device industry, e.g., ISO, QSR, GMP, GLP, GCP, MDR, IVDR, MDSAP
    • Strong interpersonal and team dynamic skills in working with organizations to address issues and execute plans, with the ability to lead and influence without direct authority
    • Strong analytical skills, mental toughness, and follow through to detect compliance trends and issues as they emerge and to progress solutions in a timely effective manner
    • Excellent verbal and written communication skills
    • Strong negotiation and facilitation skills
    • Excellent organizational and project management skills of a multicultural team
    • "Out of box" strategic thinker with strong leadership ability

Industry:

    • Biotechnology
Equal Employee Opportunity:
At Artera, we value bringing together individuals from diverse backgrounds to develop new and
innovative solutions for patients and physicians. As an equal opportunity employer, we do not
discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy),
physical or mental disability, medical condition, genetic information gender identity or
expression, sexual orientation, marital status, protected veteran status, or any other legally
protected characteristic.