Address
Form of workTitle: Global Regulatory Affairs Project Manager
Location:-Remote
Duration: 12 Months Extendable
Pay Rate Range:- $60.00 - $75.00 on w2
Summary:
Responsible and accountable for all operational aspects of cross-functional (e.g. quality systems, regulatory affairs) team as it pertains to process improvement activities. Instrumental in the design and development of global processes, specifically design and development activities.
The Global Regulatory Affairs Project Manager will focus on strategic, tactical, & operational activities for major continuous improvement project with a broad or ongoing impact.
This role will accomplish project objectives through matrixed employee teams and/or vendors who are not direct reports but for which the incumbent has direct accountability to lead.
The majority of time is spent overseeing their area of responsibility, managing project/team performance, communicating project and operational developments, planning, prioritizing and/or directing the responsibilities of project team members.
Goal achievement is typically accomplished through the performance of project team members.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
•Direct activities through creating and managing project plans, resourcing, status reporting, resolving issues, and identifying project risks and accountability for deliverables across multiple functional organizations
•Partners with cross-functional SME's in order to fulfill business objectives
•Attend various stakeholder meetings to represent the RA function, track progress, and provide status updates
•Apply and demonstrate strong leadership that results in a collaborative culture using clear, credible, objective, and proactive communication and stakeholder management, including communication with executive staff
•Establish and monitor meaningful metrics/Key Performance Indicators
•Monitor and improve tracking / control systems and dashboards
•Provide status reports of project progress to various internal leadership teams
•Review process changes/updates and assess quality and regulatory implications relative to the change
•Provide regulatory affairs support for QMS related changes to the assigned project
•Drive process and compliance improvement activities
•Ensure the project results meet requirements regarding quality, regulatory requirements, scope, schedule, and cost
•Other duties as assigned
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
Knowledge, Skills, & Abilities:
•Minimum of 7years of work experience in QA/RA or related field, including managing people and/or projects.
•Demonstrated knowledge of FDA, EU MDR, CMDR, & ISO 13485:2016 QMS regulatory requirements
•Experience with medical devices; experience with devices that contain software is a plus
•Strong attention to detail and the ability to multi-task
•Ability to prioritize, conduct team meetings, and meet project deadlines
•Exceptional project management skills, knowledge of process and project planning best practices
•Experience driving global change management initiatives across medical device manufacturing organizations
•Experience in implementing successful continuous improvement initiatives using LEAN Six Sigma methodologies, Kaizens, etc.
•Excellent communication skills and interpersonal/team effectiveness - ability to communicate to various levels of management and employees succinctly and accurately to accomplish organizational goals
•Demonstrated ability for strategic thinking, project planning, and project management
•Ability to travel up to 10% domestically or internationally
Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Education:
•Undergraduate degree or country equivalent in a scientific or technical discipline (i.e., engineering)
•MBA or similar graduate degree is a plus
•PMP Certification is a plus
•Certified LEAN Six Sigma Green Belt (or higher) or the attainment of an ASQ Certified Manager of Quality, Operational Excellence (CMQ/OE) is a plus
Location:-Remote
Duration: 12 Months Extendable
Pay Rate Range:- $60.00 - $75.00 on w2
Summary:
Responsible and accountable for all operational aspects of cross-functional (e.g. quality systems, regulatory affairs) team as it pertains to process improvement activities. Instrumental in the design and development of global processes, specifically design and development activities.
The Global Regulatory Affairs Project Manager will focus on strategic, tactical, & operational activities for major continuous improvement project with a broad or ongoing impact.
This role will accomplish project objectives through matrixed employee teams and/or vendors who are not direct reports but for which the incumbent has direct accountability to lead.
The majority of time is spent overseeing their area of responsibility, managing project/team performance, communicating project and operational developments, planning, prioritizing and/or directing the responsibilities of project team members.
Goal achievement is typically accomplished through the performance of project team members.
Essential Duties and Responsibilities:
This section contains a list of five to eight primary responsibilities of the work. The incumbent will perform other duties as assigned.
•Direct activities through creating and managing project plans, resourcing, status reporting, resolving issues, and identifying project risks and accountability for deliverables across multiple functional organizations
•Partners with cross-functional SME's in order to fulfill business objectives
•Attend various stakeholder meetings to represent the RA function, track progress, and provide status updates
•Apply and demonstrate strong leadership that results in a collaborative culture using clear, credible, objective, and proactive communication and stakeholder management, including communication with executive staff
•Establish and monitor meaningful metrics/Key Performance Indicators
•Monitor and improve tracking / control systems and dashboards
•Provide status reports of project progress to various internal leadership teams
•Review process changes/updates and assess quality and regulatory implications relative to the change
•Provide regulatory affairs support for QMS related changes to the assigned project
•Drive process and compliance improvement activities
•Ensure the project results meet requirements regarding quality, regulatory requirements, scope, schedule, and cost
•Other duties as assigned
Qualifications:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
0 N/A: Intern or Co-op
Knowledge, Skills, & Abilities:
•Minimum of 7years of work experience in QA/RA or related field, including managing people and/or projects.
•Demonstrated knowledge of FDA, EU MDR, CMDR, & ISO 13485:2016 QMS regulatory requirements
•Experience with medical devices; experience with devices that contain software is a plus
•Strong attention to detail and the ability to multi-task
•Ability to prioritize, conduct team meetings, and meet project deadlines
•Exceptional project management skills, knowledge of process and project planning best practices
•Experience driving global change management initiatives across medical device manufacturing organizations
•Experience in implementing successful continuous improvement initiatives using LEAN Six Sigma methodologies, Kaizens, etc.
•Excellent communication skills and interpersonal/team effectiveness - ability to communicate to various levels of management and employees succinctly and accurately to accomplish organizational goals
•Demonstrated ability for strategic thinking, project planning, and project management
•Ability to travel up to 10% domestically or internationally
Education and/or Experience:
Include the education and/or experience that is necessary to perform the job satisfactorily.
0 N/A: Intern or Co-op
Education:
•Undergraduate degree or country equivalent in a scientific or technical discipline (i.e., engineering)
•MBA or similar graduate degree is a plus
•PMP Certification is a plus
•Certified LEAN Six Sigma Green Belt (or higher) or the attainment of an ASQ Certified Manager of Quality, Operational Excellence (CMQ/OE) is a plus
