Job Title: VP of Quality & Regulatory Affairs
Job Number: 25413
To continue our solid growth, we are seeking a talented and highly motivated individual to join our organization as Vice President of Quality and Regulatory Affairs. The successful candidate will be responsible for strategic and functional leadership of Quality and Regulatory initiatives across a broad portfolio of instrument platforms, assays and consumables, and our CLIA-certified Accelerator Laboratory. The successful candidate will play a critical role building the quality and regulatory foundation for our strategic pursuit of growth opportunities in the field of in vitro diagnostics.
- Directs all activities relating to US FDA and analogous international regulatory compliance, such as clinical research and pre-clearance testing, required clearances and approvals, compliance with quality systems regulations, and other analogous requirements.
- Develops and implements effective strategies for obtaining necessary regulatory approvals to bring products to market with optimum cost effectiveness and compliance. Ensures timely preparation and filing of organized and scientifically valid submissions. Designs record retention practices and oversees audit preparations. Provides expertise in translating regulatory requirements into practical, workable plans. Represents the Company in interactions with relevant regulatory agencies.
- Develops effective systems and ensures compliance with the Company’s global quality assurance programs, including design, manufacturing and test, product assurance, reliability, training, and documentation.
- Supports new product development efforts, including assigning Quality representatives to Product Development Core teams. Provides critical inputs to and/or approvals of all design control elements including test development, protocols, reports, inspection instructions, Design Reviews, Design History File, etc.
- Supports certification and ongoing compliance processes to all relevant ISO, FDA and international standards (ex. ISO 13845, CLIA, QSR etc.) by facilitating the development, implementation, monitoring, and improvement of quality management systems and practices
- Manages and strengthens the infrastructure required to perform the core activities of the Quality Management System, including Deviations, Out of Specification (OOS), Corrective & Preventative Actions (CAPAs), investigations, change control, validations, material disposition, complaints, internal and external audit/inspections, and customer inquiries/questionnaires
- Collaborates with other functions to assure compliance in support of biopharma services, clinical validation studies, regulatory interactions, and medical device commercialization.
- Builds functional excellence within the Quality and Regulatory organization through excellence in hiring, ongoing professional development & performance management, and organizational design.
- Maintain an up-to-date knowledge of regulatory procedures and provide analysis and evaluation at set intervals and as needed to ensure compliance and attainment of strategy.
Skill and Knowledge Requirements:
- Demonstrated track record leading a critical corporate function; demonstrated success in leading through influence
- Comprehensive knowledge of ISO, CLIA and FDA regulations and experience in obtaining certifications, US and international regulatory agency inspections; ASQ CQE and CQA preferred
- Excellent understanding of and experience implementing Design Control in the context of new product development
- Understanding drug-diagnostics co-development, requirements to support US and international clinical validation studies, and regulatory pathways to commercialization is highly desired
- Excellent oral and written communication skills with strong technical writing experience required
- Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
- Demonstrated track record of cross-functional influence and engagement
- Highly organized and detail oriented, with an analytical approach to problem solving and decision making
- Strong working knowledge and application of the applicable quality and regulatory standards and track record of successful customer audits and regulatory inspections
Experience and Education:
- Minimum B.A/B.S. degree, preferably in an engineering or life sciences discipline
- 10+ years of experience in the biopharmaceutical, healthcare or life sciences industry, preferably in a testing laboratory, diagnostic manufacturing organization and/or a diagnostics service organization.
- 8+ years of experience working in a regulatory affairs department working on FDA regulatory submissions (PMAs, sPMAs, IDEs, SRDs, 510(k)s), leading technical professionals with demonstrated effectiveness to recruit, hire and train a team as well as provide continued guidance, mentorship and support to staff
- Experience engaging in direct negotiations with the FDA in resolving issues with submissions, experience preparing and submitting successful original PMAs and a good understanding of the multiple routes to clearance or approval of a diagnostic product
- Experience and understanding of ex-US regulatory registrations and approvals as well as understanding of HIPAA and the importance of patient data privacy
- In-vitro diagnostic (reagents and instrumentation/software) experience strongly preferred
- Proficiency with standard business tools: word processing, Powerpoint, Excel, ERP, CRM, & QMS; experience with Master Control strongly preferred.
- Passion for powering precision health