Director of Regulatory Affairs

Vision Statement:At XL Pro Staffing & Consulting, our mission is to redefine success by matching exceptional talent with outstanding opportunities. We are dedicated to providing personalized, transparent, and innovative staffing solutions that not only meet the needs of our clients but also elevate the professional journey of every individual we serve. Join us in shaping the future of work, where your skills are recognized, your aspirations are valued, and your career thrives. Explore limitless possibilities with XL Pro Staffing & Consulting– where talent meets opportunity, and success becomes a shared journey. #EmpoweringCareers #TalentConnection #CareerSuccess.

Position: VP Director of Regulatory AffairsSalary: 150K-175K

General Position Summary:The VP 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.

To:Tatiana Evans;Leticia ZunigaFri 4/12/2024 3:00 PM

Reporting to the President, the VP of Quality Assurance & Regulatory Affairs is responsible for planning, developing, and enforcing compliance programs for the company as well as leading the company's Quality Assurance efforts. This role will oversee varied compliance risk-based functions and programs such as manufacturing regulatory compliance, quality assurance programs, state licensing, FDA / third-party compliance, and other compliance activities. Leads the development of compliance programs to prevent and detect non-conformance to laws as assigned, regulations, standards, and companies' policies and ensures the implementation of a compliance program for the full organization. Develops and implements strategies, policies, procedures, and practices that establish company standards for compliance. Ensures compliance with all applicable laws, regulations, and accreditation standards, such as the National Committee for Quality Assurance (NCQA), and Occupational Safety and Health Administration (OSHA). Respond and react to changes and developments in laws or the regulatory environment that might affect compliance and implement necessary changes. Investigate, audit, and resolve alleged violations or incidents of nonconformance and verify that compliance deficiencies have been corrected. Provides key support and reporting for any Audits. May develop and implement targeted compliance training curriculum. Collaborates closely with executive leadership, operations, legal, risk management, finance, and Information Security to identify and resolve compliance issues by overall business objectives.

The Vice President (VP) of Quality Assurance and Regulatory Affairs develops strategy and supports business plans, exercises wide latitude in determining objectives and approaches to critical assignments and contributes to building and executing business strategy.

ESSENTIAL FUNCTIONSOversees the corporate compliance risk-based functions for manufacturing, product development, and quality control. Develops and implements an effective QMS.Designs and implements document procedures for process control, improvement, conformance, testing and inspection.Oversees product testing programs for product development, complaints, and other causes.Maintains registrations, complying with FDA, DEA and state regulations.Develops and communicates corporate compliance updates, progress, and status reports to the President and the Board.Leads compliance improvement programs and activities, including key response time, service quality, risk mitigation, and completion of corrective action plans.Collaborates with senior leadership to implement the compliance reviews, including risk assessment, program development, education, and program monitoring.Oversees compliance audits that includes potential problem identification and intervention to offset adverse impact.Leads the selection and development of curriculum for annual and new-hire compliance education for all employees.

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.

Education & Experience: -Bachelor’s degree in a science-related field or equivalent required.-A minimum of 6 years of previous Quality Management and Regulatory experience.-Experience in quality systems regulations including 21 CFR 820 and ISO 13485 or ISO 22716. -Experience in leading FDA medical device registration submission and maintenance including 510(k) submissions

If you are interested in this position, please send your resumes to rebecca@xlpro.com