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DATE ADDED: Thu 05/12/2019

Regulatory Affairs Specialist

Conyers, GA, US
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COMPANY: KEDPLASMA

JOB TYPE: Permanent, FullTime

Duties and Responsibilities: 1. Serves as Regulatory Affairs representative on project teams and provide regulatory guidance. 2. Develops and manage regulatory project plans. 3. Assists the Director, Regulatory Affairs in the coordination of EU audit preparation activities. 4. Ensures compliance within KEDPLASMA organization to cGMP, SOP (Standard Operating Procedures) and other Company Standards and Protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required. 5. Participate in the review of procedures and change control activities to ensure compliance with organizational standards and regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies as required. 6. Researches compliance with regulations when new procedures, policies, changes, and programs are being considered. Prepares analysis of findings and when appropriate uses a wide degree of creativity and latitude to provide strategic guidance for filing in order to achieve the business objective. 7. Performs GAP analyses of new regulatory requirements and customer specifications against current processes/procedures. Submits findings to the appropriate Departments and recommends/initiates the applicable changes to ensure compliance. 8. Assesses need and develops/revises procedures to support the Regulatory department. 9. Prepares FDA Submissions for PAS, CBE30, CBE of New and Revised Procedures, labels for current as well as new centers. 10. Compiles and submits, in a timely manner, regulatory documents according to regulatory requirements. 11. Prepares and submits BPDRs to FDA. Develops standardized response and formats for the requirements to ensure consistency and accuracy in all submissions. Works with Centers as necessary to ensure that information submitted in the field to regulatory is thorough and accurate when received by Regulatory. 12. Assist donor centers to prepare and distribute the annual Site Master File (SMF) for each collection center. Compiles information and communicates with Global QA as required to ensure accurate completion of the Plasma Master File submission. 13. Prepares correspondence and maintains communication files for external customers, suppliers, vendors, etc. including any routine and mandatory reports or updates. 14. Develops and maintains a regulatory reporting calendar of all current filing requirements, i.e. certifications, permits, filings, registrations, licenses, for each individual location, corporate entity, regulatory and governmental agency. Subsequently, tracks renewal/expiration dates for all. Develops a centralized database for all information and ensures the appropriate entities receive the documentation as necessary. 15. Reviews audit reports, provides feedback, along with recommendations for corrective action that can be implemented to assist in addressing audit report findings. 16. Participates in review and approval of Validation Procedures for Software, Equipment and processes as required by SOP and regulations. 17. Reviews and approves Standard Quality Agreements and customer specifications prior to implementations. 18. Monitors, prepares and submits epidemiological data to PPTA and contracted fractionators. 19. Assists KEDPLASMA Quality to insure that all notifications to regulatory bodies, and any “pre-opening” or “post-opening” audits are scheduled as necessary. 20. Provides support and assistance (on- or off-site) to donor centers during inspections by customers and regulatory agencies. 21. Manages departmental employees including training, performance evaluation, career development, compensation administration and progressive discipline as needed according to company policies and procedures. JOB SPECIFICATIONS: 1. Bachelor’s degree in science or minimum of 2 years plasma center experience required. Previous work experience demonstrating decision making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service. 2. Excellent communication skills and ability to conduct oral presentations. 3. Excellent people skills which extends to a diverse group of individuals and demographics. 4. Three to five years of working experience in a biomedical field preferred. 5. Ability to speak, read and write in English. Professional appearance and demeanor. 6. Ability to operate computer software including the DMS (with training), Master Control and Microsoft Office. PHYSICAL REQUIREMENTS: 1. Ability to read and review documents for up to four (4) hours at a time. 2. Ability to sit or stand for up to four (4) hours at a time. 3. Ability to tug, lift, and pull up to fifty (50) pounds. 4. Be able to bend, stoop or kneel and climb stairs and/or ladder. 5. Occupational exposure to blood-borne pathogens. 6. Able to travel by plane and drive car. 7. While performing the duties of this job, the employee is regularly required to stand; use hands to handle or feel objects, tools or controls.
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