Job Description
COMPANY SUMMARY
At Biolyst Scientific, we understand the evolving needs of clinicians and scientists in a world of supply chain disruptions and the demand for scientific advancements. We offer more than just order fulfillment—we provide partnership, expertise, and a genuine investment in your success. Our team blends industry knowledge with passion to deliver innovative solutions that drive medical and scientific progress. We are big enough to deliver, small enough to care.
POSITION SUMMARY
The Director, Quality & Regulatory Affairs provides strategic leadership and oversight for Biolyst Scientific's Quality Management System (QMS) and Regulatory Affairs functions. This position is responsible for ensuring compliance with applicable FDA, Health Canada, ISO, and other global regulatory requirements governing medical devices, drug products, chemicals and related life sciences products.
ESSENTIAL JOB FUNCTIONS
- Provide strategic leadership for all Quality Assurance and Regulatory Affairs activities across the organization.
- Serve as Management Representative for the Quality Management System and ensure ongoing compliance with ISO 13485 and applicable regulations, 21 CFR 820, CFR 210/211.
- Lead regulatory strategy and oversee preparation, review, and submission of regulatory filings and registrations, including 510K.
- Direct internal audit programs, supplier audits, management reviews, and external regulatory inspections.
- Serve as primary liaison with regulatory agencies, notified bodies, auditors, and customers.
- Oversee supplier quality management, CAPA, nonconformance, complaint handling, change control, and document control processes.
- Lead the Stability Program by ensuring the development, execution, review, and approval of stability studies; evaluating stability data and trends;
- Review and approve product labeling, packaging, promotional materials, technical documentation, and quality records.
- Collaborate with cross-functional teams to support product development and commercialization.
- Develop quality and regulatory metrics, dashboards, and reports for leadership.
- Recruit, develop, mentor, and manage quality and regulatory personnel.
MINIMUM REQUIREMENTS
- Bachelor's degree in Regulatory Affairs, Life Sciences, Pharmacy, Engineering, Quality Management, or a related field required.
- Advanced degree preferred.
- 8–10 years of progressive experience in Quality Assurance and/or Regulatory Affairs.
- 3–5 years of leadership experience managing quality and regulatory functions.
- Demonstrated expertise with cGMP, FDA regulations, ISO 13485, ISO 14971, CFR 820, CFR 210/211 and related standards.
- Experience leading inspections, audits, and regulatory agency interactions.
- Excellent leadership, communication, organizational, and project management skills.
- Bilingual English/Spanish proficiency strongly preferred.
Electron Microscopy Sciences/Azer Scientific provides equal employment opportunities to all persons and prohibits employment decisions based on race, religion, color, creed, national origin, sex, age, disability, political affiliation, protected veteran status, or sexual orientation.