ABOUT spencer®

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.

WHY Spencer?

We are one of North Carolina’s fastest growing startups, and that is a big thanks to each one of our employees hard work!  

Our culture is extremely important to us, and you can see it in the passion that our team members have for the company.   Spencer Health Solutions offers competitive salaries, a hybrid work environment, and a flexible schedule!  We prioritize health and wellness with subsidized healthcare packages for you and your family, including vision, dental, life insurance, and long-term and short-term insurances.   We invest in your continued education by providing lunch and learns and individual development plans.  We also like to have fun! We provide a snack bar, quarterly celebrations including food trucks, and have a free gym on premise!

We place high importance on the health, happiness, and success of our team members. 

Come work with us!

The QA / RA Director is responsible for building, advancing and sustaining the Spencer Health Solutions quality management system and ensuring that it meets applicable state, federal, and international regulations and business elected quality standards.  Additionally, this individual is responsible for establishing a Regulatory strategy and maintaining compliance with applicable regulatory requirements.

RESPONSIBILITIES

• Lead maintenance and advancement of the company Quality Management System including sustaining its certification to ISO 13485.
• Establish and maintain compliance with Class I/II medical device regulatory requirements for the US, Canada, and the EU through definition of a Regulatory strategy and ongoing reviews of product and regulatory guidance changes.
• Lead organization through the MDD / MDR transition.
• Establish and maintain compliance with Data Privacy and Security regulatory requirements
• Serve as the Organization’s Management Representative, the point of contact for all quality and regulatory communication with applicable agencies and bodies.
• Own key Quality Management System Processes including CAPA, nonconformances, supplier controls, document control, change control, training and customer complaints.
• Responsible for working with Engineering and Operations to advance the Design Control systems and develop validation / qualification protocols and Risk Management files that meet applicable Regulations, Guidance and Procedures.
• Conduct internal audits and coordinate and manage external ISO / Regulatory audit schedules, correspondence and closing of findings
• Effective and timely review of change orders and technical documentation.
• Review / audit / approve DMR and DHF and ensure Technical File is kept updated.
• Responsible for managing QA / RA department – including internal and external resources and partners.
• Responsible for reviewing and establishing the company quality goals each year and leading Management Reviews.
• Establish and Publish Department KPIs.

• BS/MS in Engineering or equivalent technical degree.
• 10+ years of medical device management experience.
• Demonstrated aptitude in leading teams / organizations that comply with 21CFR820, SOR /98-282, MDD 93/42/EEC, CE and ISO13485
• Regulatory compliance related to medical device industry including experience submitting medical device license applications for US, Europe, and Canada and maintaining Notified Body / EU Representative relationships.
• Knowledge of Data Privacy and Security Regulations and Standards
• Proven experience working directly with domestic and foreign regulatory authorities
• Ability to analyze and interpret standards and government guidance and regulation documents and translate into internal strategies and policies.
• Ability to write standard operating procedures, work instructions, specifications, and technical reports
• Ability to effectively communicate company status, goals, and initiatives throughout the organization
• Demonstrated success in leading teams / departments, including external partners.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization
• Hands-on leader willing to work side by side with a small, agile team.

PREFERRED

• Certified Quality Auditor (CQA) and Regulatory Affairs Certification (RAC)

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.

Your safety and privacy is of our utmost concern. Any communications with a Spencer Health Solutions employee will be through an email originating from @spencerhealthsolutions.com or [email protected].  We will never ask for your private information until an official offer has been accepted.