What you'll be doing:
- The primary responsibility of the Regulatory Affairs Specialist III will be to ensure compliance with laws/regulations and established internal control procedures while serving as a regulatory resource within a quality affairs environment.
- Duties to include: working with cross-functional teams to ensure alignment and consistencies between quality management systems standards (e.g. ISO) and applicable regulations.
- Additionally, scheduling/conducting of pre-audit meetings, serving as lead internal auditor and conducting audits using FDA QS/GMP and ISO 13485 as guiding principles.
- Also expected to maintain Drug Master Files, communicate audit findings and, where necessary, management of CAPA.
- Maintain professional and technical knowledge by attending educational workshops, reviewing professional publications and establishing networks.
- Minimum of 3-5 years of direct quality assurance experience.
- Preferred regulatory experience from a manufacturing environment and working with biological reagents.
- Preferred regulatory experience with systems consisting of hardware and software reagents interfaces.
- Demonstrated knowledge of FDA Quality System GMPs.
- Preferred competency as a lead auditor of ISO (13485 ) quality management system.
- Must be customer focused with strong organizational and time management skills.
- Excellent written and verbal communication skills possessing an attention to details, thoroughness, presentation and objectivity.
- Competitive pay and great benefits including medical, dental, vision, 401k and more.
- Opportunities for growth and training.
- Stability of a profitable 60+ year old company.
- Great work environment.
- Our company is a global leader providing a broad array of clinical diagnostics and life science research products.
- With a team of more than 7,800 employees and a global network of operations serving our customers, we help people live longer, healthier lives.
- Our company was founded over six decades ago and has continued to provide the healthcare industry with innovative and useful products that help life science researchers accelerate the discovery process and medical diagnostic labs obtain faster, better results.
- EEO/AA Employer/Veterans/Disabled/Race/Ethnicity/Gender/Age