Responsibilities

• Serve as the primary Quality and Regulatory Affairs adviser for the promotion and commercialization of Concentric products and services. Key activities may include, but are not limited to:
• Serve as regulatory approval for quality, technical and/or safety communications.
• Identify and mitigate quality and regulatory risks in collaboration with stakeholders. Manage quality systems, and inform senior leadership in compliance with quality system requirements. May conduct or support quality and regulatory audits, monitoring and/or inspections.
• Support implementation and continuous improvement of quality system policies and procedures, including delivery of training, to meet best practice standards and/or improve quality and the user experience for clients and end-users.
• Collaborate with internal partners, including the Legal team, to provide actionable and strategic advice for business and operations teams.
• Provide advice to clients working with and developing products for surveillance, diagnostics, and CLIA labs. Participate with leadership in setting strategic direction and developing the capabilities of the QA/RA team.
• As assigned, lead or otherwise participate in special projects and act as a standing or ad hoc member of other teams

Minimum Requirements

• Bachelors degree and 10 years of related experience
• Highest level of knowledge of industry quality and regulatory standards and processes, particularly in FDA-regulated environments
• High level of knowledge of business operations, objectives and strategies
• High learning agility
• Excellent problem-solving and decision-making skills. Applies risk-based problem solving and appropriate business solutions to effectively mitigate compliance risk. 
• Experience with cross-functional problem solving and driving change through to successful implementation. 
• Effective in assessment of compliance risks and the ability to communicate potential business impact.
• Excellent influencing skills. Proven track record and experience in building and cultivating relationships with key partners and stakeholders across organizational levels. Excellent client service, negotiation, leadership, and communication skills.
• Strong process-orientation with proven effectiveness in identifying, developing and implementing scalable/sustainable processes and other continuous improvements to achieve organizational efficiencies and increase effectiveness.
• Proven ability to work autonomously

Preferred Capabilities and Experience

• Bachelor's degree in life sciences or business
• 10 years of experience supporting biotechnology or life sciences companies in FDA and related regulated fields
• Technical knowledge of products to be supported
• Industry experience with advertising and promotional communications approval process
• Experience managing Corrective and Preventive Action (CAPA) activities
• Experience in performing and responding to audits, inspections and risk assessments