Join the LEBW Team!

Specialist, Regulatory and Compliance
Reports to:  Manager, Quality Services
2^nd Echelon Reporting:  None
FLSA Status: Exempt
Compensation Level: 6

Position Objective

Responsible implementing strategic plans, policies, and procedures at all levels of the organization so quality improvement efforts will meet or exceed internal and external requirements and expectations. Assures organizational compliance to FDA regulations, EBAA medical standards, OHSA and Lions Eye Bank of Wisconsin, Inc. policies and procedures through comprehensive program of monitors, audits, and quality assurance programs.  Works with the leadership team members to implement and monitor key quality performance indicators.

Essential Duties of the Position

1. Monitor, analyze, and trend compliance to FDA regulations, EBAA medical standards, OSHA, Wisconsin statutes and LEBW standard operating procedures. Manages all regulatory local, state and federal reporting requirements.
2. Incorporate new regulatory policies into organization protocol through the oversight of an administrative system involving document and change control.
3. Manage the timely, comprehensive, and efficient quality assurance audit of donor records to ensure procedures comply with EBAA medical standards, FDA regulations, Wisconsin statutes and the internal policies and procedures of LEBW.
4. Oversee the internal audit system (plan, communicate, conduct, and report internal audits, and maintain audit files and records and oversee corrective actions).
5. Host external audits (plan, document, and act as primary contact) and respond to audit findings.
6. Manage the review and assessment of Departures from procedures and Deviations for additional correction or initiation of corrective/preventative actions and reporting if necessary.
7. Oversee Complaint Handling, Adverse Reaction/Event Reporting, Deviation Reporting, Recall, and Regulatory License/Registration systems.
8. Provide expertise and guidance regarding domestic and international regulatory and quality requirements needed to meet complaints, adverse reactions/events, regulatory reporting, internal and external auditing, document preparation, performance metrics and review of controlled documents.
9. Recommend corrective/preventative actions pertaining to FDA regulations, EBAA medical standards, and LEBW SOPs.
10. Interact with Medical Director on key issues regarding standards, regulations, and procedures and report outcomes to the Executive Director.
11. Assures equipment, software and supplier qualification and validation in compliance with established regulations and quality standards.
12. Develop, implement, and monitor quality audit processes for technical procedures.
13. Participate in new product and service development to assure regulatory and quality standards are met.
14. Investigate Adverse Reaction Reports and file appropriate reports with EBAA and FDA and report outcomes to the Medical and Executive Directors.
15. Investigate positive serology reports and initiate state reporting when necessary.
16. Manage and act on supplemental or after-the-fact donor eligibility information.
17. Review and audit monthly quality control processes.
18. Ensure staff training is properly documented. Provide assistance instructing staff in quality control, assessment and analytical procedures.
19. Maintain policy and procedures for compliance with OSHA requirements.
20. Other duties as assigned.

Minimum Education & Experience Requirements

• BS Degree preferred, or the equivalent of combined education and related work experience.
• 2-3 years regulatory/compliance experience in scientific or medical field.
• Prefer expertise, skills, and knowledge of ophthalmology, recovery, and transplantation and/or eye bank procedures.
• Knowledge of FDA, CGTPs, CGMPs, AATB, EBAA and /or other related regulatory standards.

Knowledge, Skills, and Abilities Necessary to Perform Essential Functions

• Excellent verbal and written communication skills.
• Knowledge, skills, or experience in clinical and surgical procedures, ophthalmic surgical assisting, and/or organ, tissue, and/or eye bank procedures.
• Experience with FDA and/or other regulating authority inspections preferred.
• Equipment qualification and process validation experience preferred.
• Ability to prioritize and multi-task.
• Ability to read, interpret, and communicate FDA regulations and EBAA medical standards.
• Ability to work with all levels of medical personnel in urban and rural hospitals.
• Ability to perform a variety of duties, often changing from one task to another of a different nature.
• Ability to perform with frequent interruptions and/or distractions.
• Ability to work independently and identify potentially more effective methods of work operations.
• Computer literacy including Word processing and database software.

Physical/Environmental Demands of the Position

• Physical Activities – Sitting, standing, reaching, bending, and stooping. Manual dexterity for use of computer and office equipment.
• Level of Physical Requirements – sedentary to light work. May be asked to carry supplies weighing up to 40 pounds.
• Environmental Conditions – Primarily office setting. Inside environment, exposure to clinical/hospital setting, or office environment. May be exposed to computer screen and other office equipment to include telephone. May also be exposed to corneal tissue, cornea preservation media, and other recovery supplies and reagents.

Email resume with cover letter to careers@lebw.org.