Spencer Health Solutions (www.spencerhealthsolutions.com) is transforming healthcare by moving care delivery to the home through the company’s spencer® medication adherence and engagement platform. The spencer FDA Class I technology enables virtual care by connecting patients, clinicians, pharmacists and family members digitally.

The Morrisville company offers the right candidate an opportunity to be part of a high-performing team in the development of cutting-edge medical technology at the exciting point of market entry through leading health technology distributors in the US, Canada and Europe.

Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.

The VP of RA/QA is responsible for implementing and managing Spencer Health Solutions quality management system to ensure it conforms to the standards and regulatory requirements for our industry and to work with internal and external resources to ensure our products meet the highest applicable standards as well as regulatory requirements. The ideal candidate will have significant experience in the Regulatory/QA space with excellent leadership/management skills.

RESPONSIBILITIES

• Ensure that Spencer Health Solution’s Quality Management System is established and maintains effective quality assurance processes and compliance to the regulatory requirements of the industry, including the International Standards: ISO 13485, FDA Quality Systems Regulations (QSR, 21 CFR Part 820) and Medical Device Directive (MDD93/42/EEC)
• Responsible for planning, scheduling, and organizing QA activities related to meeting the compliance, supply, profit plan, and strategy objectives of the company
• Responsible for overall planning and management of QA systems to ensure continuous production of sale and reliable products consistent with established standards and regulatory requirements
• Act as a subject matter expert regarding all Quality Assurance practices and procedures for the company, including global offices
• Implement control systems to ensure consistent quality standards are achieved including inspection and testing procedures for raw materials, process and finished goods and supplier evaluation and approval process
• Oversee the Regulatory Affairs for the company and ensure compliance with national and international standards and legislation related to quality systems and products
• Maintain an up-to-date knowledge on all regulatory matters
• Advise senior management of potentially significant changes and risks
• Develop training, procedures according to regulatory requirements to ensure regulatory compliance, including early in the new product development process
• Communicate all these requirements to appropriate teams and provide training and guidance when needed
• Negotiate with domestic and foreign regulatory authorities to obtain agreement for optimal regulatory strategies
• Compile and write submissions to domestic and international regulatory authorities including 501(k) Premarket Notifications, Investigational Device Exemption applications, and all appropriate responses and reports
• Maintain regulatory approvals in specific geographies
• Monitor worldwide trends related to Regulatory and QA
• Interact with various regulatory agencies to accomplish product clearances
• Create an environment of open communication by utilizing interpersonal skills that effectively allow the team to function properly with an understanding of the company objectives as well as issues of importance
• Make recommendations for strategic changes to the internal procedures and processes to improve efficiency
• Provide leadership for the implementation of Lean processes and improvements, including developing training programs
• Represent Regulatory and Quality Assurance at relevant internal and external meetings
• Provide leadership, oversight, and direction to all functional teams regarding quality
• Ensure corporate-wide quality compliance and fast operational execution
• Interface with customers regarding quality and regulatory issues and business development opportunities
• Provide leadership, oversight, and direction to all functional teams with best practice and compliant cost-effective business alternatives
• Integrate the needs of the quality function with the needs of the management team and business processes across all departments and enforce requirements as specified by regulatory agencies

• BS degree in a technology or science related discipline
• 10+ years of Regulatory and QA experience, preferably in the medical device industry or other FDA regulated environment
• 5+ years’ experience in establishing, implementing and maintaining quality systems that meet the requirements of CMDR/ISO 13485, FDA/QSR, MDD is required
• Experience working in a lean manufacturing environment
• Demonstrated leadership, technical aptitude, and problem-solving skills
• Proven experience working directly with domestic and foreign regulatory authorities
• Knowledge of QSR, ISO, CE and QA principles
• Regulatory compliance related to medical device industry including experience submitting medical device license applications for US, Europe, and Canada
• Proven expertise navigating through FDA requirements and licensing procedures
• Excellent communication skills, including verbal and written.
• Ability to handle ambiguity and bring solutions
• Experience working in a regulated environment
• Ability to read, understand, and execute job functions in accordance with  Standard Operating Procedures

Spencer Health Solutions is an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and the basis of disability or any other federal, state or local protected class.