Descripción del Trabajo
The Global Quality Regulatory Affairs Manager provides global support to leadership and management of Jabil’s Regulatory Affairs within the Medical Business Units, Manufacturing and Design operations. This role provides subject matter expertise in interpretation and practical application of FDA and international medical regulatory requirements, quality management systems and quality assurance programs. Position is responsible for defining and assisting in the deployment of global policies and procedures pertaining to regulatory requirements and standards. The manager will provide training, monitor compliance, risk assessment, and assist Regulatory Affairs managers and design teams to prepare packages for FDA submission in various site. This position will assist and support the Regulatory Affairs & Quality Managers at Jabil sites in the development, creation, and documentation of world class quality and business system improvements, as well as support for customer and/or ISO/FDA escalations and FDA QSIT inspections as needed.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provide subject matter expertise (SME) in interpretation of ISO9001, ISO13485, FDA 21CFR Part 820, SFDA, Japanese MHLW , ANVISA and other standards (domestic or international) relevant to the medical sector. To become familiar with other standards as applicable.
- Subject matter expert in class I, II, and III medical devices regarding requirements, documentation, and submissions
- Ensure functional management and business management are aware of and understand the principles and expectations associated with the above-mentioned standards through training
- Act as a facilitator to Jabil management in the standardization and simplification of the standards. This will include not only auditing and training of the system, but offering interpretation of standards and suggesting means / methods of improving elements and practices within the system.
- Understanding of risk analysis for medical devices using FMEA, FTA and other techniques.
- Experienced in planning and executing software validation for medical device and manufacturing processes. (Experience in system validation compliant with 21CFR part 11)
- Extensive experience in tools validation
- Understanding of medical device compliance issues and regulatory submission requirements.
- Practical experience in deploying Good Manufacturing Practice (GMP) and Good Documentation Practices (GDP)
- Implement effective, compliant quality systems and development of standards related to design and software control.
- Learn Jabil Business Model
- Train all Design teams regarding class I, II, and III medical device requirements
- Review Design that are in progress and ensure all activities are documented properly & according to requirements for each specific class.
- Verify plan for introduction of new products, devices, and customers
- Work with sites to identify and close compliance gaps
- Ensure sites are FDA QSIT ready
- Participate in all FDA QSIT inspections
- Review and update where necessary, all global medical policies, procedures and templates pertaining to regulatory requirements and Implement globally
- Review Quality Agreements between Jabil and OEM partners from the regulatory point of view
- Review Design Controls. Verify management of agreements between customers and Jabil.
- Performing and documenting comprehensive risk assessment relating to regulatory affairs. ( for presentation to exec mgmt)
- Establish systemic method to monitor compliance and risk
- Standardize training within WorkDay for IL and DL for all EMS Healthcare workcells
LEADERSHIP AND MANAGEMENT RESPONSIBILITIES
Employee and Team Development:
- Assist QS & Compliance managers to create and/or validate training curriculum in compliance with medical requirements.
- Coach and mentor Jabil sites to deliver regulatory affairs excellence to internal and external customers.
- Establish clear measurable goals and objectives by which to determine individual and team results (i.e. operational metrics, results against project timelines, training documentation, knowledge of operational roles and responsibilities).
- Solicit ongoing feedback from business units for effectiveness of regulatory support
- Provide ongoing coaching and counseling to team members based on feedback.
- Drive self to continuously improve in key operational metrics and the achievement of the organizational goals.
- Assist to coordinate activities of medical initiatives as required and keep focused in times of crises.
- Establish strong relationship with Quality SVP, BU team, Ops VPs, Site Ops Mgr and site RA/QA Mgr
- Assist to establish process to share Best Practices and Lessons Learned
- Organize verbal and written ideas clearly and use an appropriate business style.
- Able to switch communication style to an internal consultant when presenting audit findings to stakeholders.
- Focus communications meetings on enhance the continual improvement efforts.
Business Strategy and Direction:
- Know and understand regulatory standards and compliance requirements at expert level. Must be an expert in class I, II, and III medical device manufacturing and submission requirements
- Define, develop and implement regulatory affairs strategy and create necessary checklists
- Provide regular updates to Director and SVP of Quality on the execution of the strategy and Regulatory Affairs activities.
- Align activities such that they serve to check and validate overall Regulatory, quality & business strategies implemented.
MANAGEMENT & SUPERVISORY RESPONSIBILITIES
- Typically reports to Management. Direct supervisor typically includes: Director of Quality Systems
- No management of direct reports
- This is a hands-on role to support our EMS global medical operations which requires an energetic and motivated self-starter with a passion.
- Extensive understanding and working knowledge of ISO9001, ISO13485 and FDA Regulations QSR/21 CFR 82, and international regulatory requirements such as SFDA, ANVISA, MHLW, EU Directives.
- Previous class I, II, and III submission experience required.
- Experience with registration/listing of products with FDA and in various countries as well as “Technical File” creation and CE marking of products.
- Strong and convincing communication and influencing skills.
- Proficiency in use of personal computers, Microsoft Office products (Excel, Word and PowerPoint) and e-mail skills required.
EDUCATION & EXPERIENCE REQUIREMENTS
- Bachelor's Degree required.
- Degree in Business Management preferred.
- Minimum of 7 years work-related experience required, preferably in Healthcare Quality Systems
- Participation in the front room for a minimum of 5 FDA QSIT inspections
- Or a combination of education, experience and/or training.
This job cannot be performed remotely in the state of Colorado.