Job Title: Director QA/RA
Department: Regulatory Affairs and Quality Assurance
Reports To: Sr. VP, Regulatory Affairs and Quality Assurance
The Director, QA/RA will be responsible for monitoring and maintaining the Quality Management System in compliance with the corporate Quality Policy, corporate and department goals and objectives and external regulations including US FDA Quality System Regulations (QSRs), CLIA, ISO 13485 and other worldwide in vitro diagnostic device regulatory requirements as appropriate. Management Representative responsible for establishing, maintaining, improving and reporting the status of the Quality System.
Position Within The Organization:
- Conducts annual Management Review [chair]
- Conducts monthly QA corporate KPI meetings [chair]
- Department meetings [participant]
- Working groups [participant/chair]
- Participates in internal and external regulatory audits [participant/lead]
Essential Duties and Responsibilities:
- Develops and enhances Quality Management System and ensures full audit-readiness for Agendia, Inc. and Agendia NV.
- Oversees Customer Complaint handling function to ensure proper and timely complaint handling, root cause identification, and complaint closure. Monitors complaint review and trend analysis.
- Responsible for post-market surveillance and vigilance reporting for product incidents to all approved markets.
- Defines, implements and directs quality activities for new product development including adherence to Design Controls procedure.
- Provides support to manufacturing in proactive resolution of quality issues, root cause failure analysis and troubleshooting.
- Oversees all aspects of Supplier Quality controls.
- Works proactively with the laboratory Operations staff to identify and correct quality problems with products and processes.
- Manages facilities inspections by state, federal and international regulatory agencies, specifically California Department of Health Services, US federal FDA, ISO, CAP, CLIA.
- Identifies regulatory requirements for changes to existing products.
- Review and approve labeling/marketing materials for compliance with applicable regulations and standards.
- Review new and existing regulations, guidance documents and standards and prepares comments based on impact to new and existing products and business.
- Manages performance of staff towards department and company goals, including feedback on performance.
- Co-develops and maintains department expense budgets in support of the annual Business Plan
- Performs other related duties as required or assigned
The above listing represents the general duties considered essential functions of the job and is not to be considered a detailed description of all the work requirements that may be inherent in the position.
Key Business Results and Deliverables:
Key business results
- Maintaining compliance to worldwide regulatory standards and regulations including ISO 13485, U.S. CAP accreditation, CLIA certification and FDA QSR
- ISO 13485:2016 compliance
- CE marking of MammaPrint, BluePrint and other products as applicable
- Enhanced QMS development including Supplier Quality controls
Education and Experience Requirements:
Requires a Bachelor’s degree in life science or related discipline or a combination of equivalent work experience and education.
10+ years overall working experience, with at least 5+ years direct QA or RA experience.
- Deep experience with regulatory submissions and compliance processes as related to Class II medical devices for both US and global markets.
- Good working knowledge of IVD/Medical Device Regulations, standards, submission, Technical Documentation and CE certification (ISO 13485, IVDD/IVDR and 21 CFR Part 820).
- Good working knowledge of EMEA and FDA regulations concerning device submissions.
- Experience in regulatory audits, ISO certification, GxP requirements (such as GDP, GMP, GLP).
- Medical software product experience, especially software validation, a strong plus.
Skills and Qualifications Requirements:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to individuals with disabilities to perform the essential functions.
- Excellent communication skills, both verbal and written
- Team player with strong belief in cross-functional collaboration
- Problem solving
- Leadership skills
- This position will supervise a Quality Specialist
- General office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Maintains a clean, neat, and orderly work area.
- Adheres to Department Specific Safety Guidelines.
- Ability to travel both domestic and international (10%)
Standing, sitting, walking, bending, reaching, manual manipulation, and lifting up to 25 pounds.