Quality Assurance and Regulatory Affairs Manager
- 2501 Aerial Center Pkwy, Morrisville, NC 27560, USA
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.
The Quality Assurance and Regulatory Manager is responsible for maintaining the quality management system and ensuring that it meets applicable state, federal, and international regulations and business elected quality standards.
- Establish and maintain company certification to ISO 13485
- Establish and maintain compliance with Class I/II medical device regulatory requirements for the US, Canada, and the EU.
- Establish and maintain compliance with Data Privacy and Security regulatory requirements
- The QA/RA Manager is the Management Representative. The duty of this position is to be the point of contact for all regulatory communication including FDA incident reporting, audits, and registrations.
- Responsible for the nonconformance and customer complaint systems.
- Responsible for working with Engineering and Operations to develop validation/qualification protocols and final reports including results and a recommendation for approval or disapproval.
- Conduct internal audits and coordinate and manage external ISO / Regulatory audit schedules, correspondence, and closing of findings
- Effective and timely review of change orders, technical data/reports, and company contracts/agreements
- Review/audit / approve DMR and DHF
- Responsible for documentation handling, storage, and change control processes
- Responsible for managing QA department training
- Responsible for managing the CAPA system
- Responsible for supporting the review, audit, and approval of vendors
- Responsible for reviewing and establishing the company quality goals each year
- BS/MS in Engineering or equivalent technical degree.
- 5+ years of medical device management experience.
- Knowledge of 21CFR820, SOR /98-282, MDD 93/42/EEC and ISO13485
- Knowledge of Data Privacy and Security Regulations and Standards
- Ability to analyze and interpret standards and government guidance and regulation documents
- Ability to write standard operating procedures, work instructions, specifications, and technical reports
- Ability to effectively communicate company status, goals, and initiatives throughout the organization
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.