Director Of Regulatory Affairs

 

Description:

The Senior Director of Regulatory Affairs manages and maintains the Company’s regulatory compliance and quality assurance programs. Oversees regulatory inspections and ensures the timely filing of documents, records, and reports with the various regulatory agencies. Serves as the Designated Representative, responsible for ensuring compliance with state and federal laws and regulations regarding wholesale distribution. Stays abreast of regulatory updates and changes, trains staff, and aligns the Company’s operating procedures, compliance standards, and quality assurance program, accordingly.

 

Essential Job Functions:

1. Develops, implements, manages, and integrates an effective QMS that aligns with management’s corporate vision, Company goals and objectives, and state and federal regulatory requirements. Establishes and implements metrics (process capability, control charts, measurement quality) to monitor system effectiveness and assist management in making sound product quality decisions.

2. Serves as the internal and external resource on compliance-related issues and concerns, regulatory requirements, and quality control programs. Answers employee/management questions, interprets regulatory requirements, serves as primary contact during regulatory inspections, and assists in problem identification, resolution, loss reporting, and continuous improvement plans. Investigate non-conformances, deviations, and customer complaints and identify effective corrective actions and process improvements.

3. Initiates and maintains registrations to comply with FDA, DEA, and state registrations, including DSCSA and UDI. Reviews and updates medical device listing and Master Production Records and Product Examination reports. Reviews, maintains, and updates Standard Operating Procedures (SOPs) and files appropriate documents. Maintains Safety Data Sheets program. Submits trademark renewal and copyright applications, as required.

4. Designs, implements, and documents procedures for process control, process improvement, product conformance, testing, and inspection.

5. Participates in product and label reviews on all manufactured products and supports engineering and design efforts by participating in product development projects to determine if design changes warrant regulatory submission with the FDA.

6. Oversees product testing program, in response to complaints, for product development, and all other causes. Researches and retains qualified testing entities and oversees calibration and testing programs.

7. Stays abreast on updated regulatory requirements and other compliance-related issues reports relevant management changes and implements and updates the Company’s overall Quality Management System.

8. Educate and train employees as to their impact on the quality management system.

9. Performs other duties as assigned.

 

Knowledge, Skills & Abilities:

1. Extensive knowledge of computers, internet, web-based systems, Word, Excel, and email systems.

2. Extensive knowledge of medical device or cosmetic and skincare products and services.

3. Knowledge of scientific principles and practices.

4. Strong computer skills.

5. Strong negotiation skills.

6. Strong written communication skills.

7. Ability to effectively and fluently read, write, and speak the English language.

8. Ability to work independently.

9. Ability to listen attentively and use skillful questioning to clarify a situation.

10. Ability to handle multiple projects/tasks and meet deadlines.

11. Ability to organize and prioritize work responsibilities.

12. Ability to effectively function under pressure and maintain control.

13. Ability to read, analyze, understand, and accurately interpret both the oral and written word.

14. Ability to express oneself in a clear, concise, and professional manner in interactions with others and written communications.

15. Ability to analyze situations using logical, systematic, and sequential approaches in order to make difficult decisions and effectively solve problems promptly.

16. Ability to anticipate the implications and consequences of situations and take appropriate action.

17. Ability to effectively speak in front of groups, co-workers, and vendors.

18. Ability to gain others’ support for ideas, proposals, and solutions.

19. Ability to be flexible and modify one’s preferred way of doing things.

20. Ability to cooperatively collaborate with others and function as a team player.