Cook Group

Project Manager

• Work with key stakeholders to define full project scope and lead the planning for assigned projects.
• Establish meeting agendas, facilitate team discussions, and drive clear and timely team actions and decisions.
• Pro-actively addresses barriers and risks to project progress, keeping leadership informed of critical considerations and the implications of priority decisions.
• Ensure that project deliverables are achieved on or ahead of schedule, within budget, and with quality that meets or exceeds business needs.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Manages scheduled and ad-hoc project status reporting.
• Manage project communication for all entity stakeholders, including providing leadership updates.
• Lead and facilitate conversations between functions when there is new information, including scope changes, risks, and competing priorities.
• Expert in listening and understanding what motivates team members and stakeholders to establish and maintain engagement and support.
• Must maintain company quality and quantity standards.

Project Manager, Research and Development

Manager

• Collaborate with key stakeholders to establish, measure, and meet business plan goals for assigned specialty and geography.
• Support accelerating market adoption for the assigned specialty.
• Provides product & market support.
• Responsible for being the regional product champion/expert.
• Collaborate with key stakeholders to ensure consistent messaging for the assigned specialty.
• Support conversions with key customers for the assigned specialty.
• Answers sales & customer questions for the assigned specialty.
• Support product launch, campaign planning & execution.
• Provide consistent program-related field communications.
• Present launch content to sales & support internal sales meetings.
• Collaborate on sales tools and messaging needs.
• Create market updates to send to the field.
• Responsible for customization of large accounts.
• Responsible for actively engaging CRM as a key tool for communication & sharing customer & market insights back into the organization.
• Initiate focus campaigns in cooperation with sales.

Market Development Manager

Marketing

• Contributes to the development of strategic objectives for marketing projects and campaigns
• Collaborates with the agency to initiate projects and develop project plans for marketing campaigns and content
• Understands the audience and objective of marketing projects to help identity appropriate reviewers and collaborators
• Performs desktop research on markets and competitors
• Manages marketing channels with limited supervision, working closely with events and digital marketing teams
• Assists marketing managers with marketing planning duties or projects, as assigned
• Engages with sales team through CRM and other communication methods to support launch of marketing tools and gain feedback
• Collaborates with digital marketing team, to analyze campaign data and provide reports to marketing managers
• May support more than one specialty
• Works independently with limited supervision on larger, moderately complex projects
• Uses prior experience, analysis, and a broad understanding to find solutions to difficult, and sometimes, complex issues
• Foster and maintain a workplace culture respectful and supportive of individual differences
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Must maintain company values, policies and standards
• Must have effective oral and written communication skills

Marketing Specialist

Compliance

• Prepare Medical Device Files for submission to regulatory authorities, with a focus on European Notified Bodies
• Maintain Medial Device Files and other regulatory documentation
• Maintain regulatory license databases and systems which contain regulatory approval or restriction information
• Liaise with relevant departments at Cook Australia and at other Cook sites, as necessary, to understand and collate information required for regulatory submissions
• Communicate with regulatory agencies and conformity assessment bodies
• Provide regulatory support to engineering projects, as necessary
• Review global marketing materials for compliance to relevant advertising guidelines
• Perform administrative tasks, including document formatting, and preparing documentation for the internal change control process.

Regulatory Affairs Specialist – 12 Month Fixed Term Contract

QA Engineer

• Direct and maintain a scalable, global structure for post market quality assurance ensuring clear communication and alignment with regional regulatory needs and business objectives.
• Develop and lead strategic vision and objectives for the global post market quality assurance team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives.
• Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
• Provide leadership and mentorship and technical expertise to a diverse geographically dispersed post market quality assurance team, ensuring alignment with global standards and regional needs.
• Oversee and manage post market quality assurance budgets, including cost tracking, and strategic planning to support global operational priorities.
• Oversee and ensure that all post market quality activities comply with applicable regulations, including but not limited to: ISO13485, US FDA CFR Part 820, State Council Order No. 739- China, PMD Act, Law Act 145- Japan, Medical Device Management Act- Taiwan, Medical Devices Act- Korea, Good Distribution Practices-Thailand, etc. Proactively monitor regulatory changes and lead updates to post market quality assurance to maintain compliance.
• Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness.
• Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance. Lead cross-functional collaboration to optimize post market quality assurance processes.
• Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
• Establish and maintain global best practices, standardised policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMQA work outputs and systems. Balance standardization with regional flexibility where necessary.
• Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMQA activities.
• Ensure local and corporate entities fulfil PMQA economic operator roles and responsibilities, including those for in-country representatives.
• Oversee the health of the PMQA QMS through proactive data collection, trend analysis, and implementation of improvement actions.
• Direct leadership to ensure compliance of the PMQA QMS with global QA policies, procedures, and direction.
• Oversee customer complaints, recall, and adverse reporting processes, ensuring appropriate handling, escalation, and resolution by relevant teams.
• Serve as the Global Process Owner and represent Cook during internal and external audits.
• Represent PMQA globally, participating in working groups and supporting the voice of Cook and patients in industry guidance and regulation commentary.
• Ensure post market quality assurance team members possess the requisite technical skills, experience, and training to perform their work.
• Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
• Foster and maintain a positive, inclusive and productive work environment aligned with Cook’s culture and values.
• Maintain overall accountability for PMQA QMS performance, communicating effectiveness and improvement needs to executive management and ensuring timely corrective actions.

Director – Post Market Quality Assurance

• Maintain knowledge of regulations applicable to submissions for medical devices and understand their impact on projects
• Must be able to rapidly learn new technical subjects and communicate technical and scientific information to project teams and regulatory authorities
• Communicate regularly with the Director of Regulatory Science to understand goals/priorities, to develop project plans, and to facilitate project progress
• Assess new technologies for regulatory pathways
• Collaborate and interact effectively with cross functional teams (e.g., Business Units, Engineering, Clinical, Marketing) to develop and implement a scientifically sound regulatory strategy for a project team in-line with project timelines
• Provide critical scientific review and regulatory-based guidance through all phases of a project; provide direction in non-clinical and clinical strategy development and review non-clinical and clinical data for accuracy, completeness, and suitability for submission to regulatory authorities
• Write, and/or coordinate the preparation of clear and effective documents, including submissions to global regulatory authorities
• Provide direction and leadership from a technical, scientific, and regulatory point of view to project teams pursuing approval of new devices and/or maintaining existing approvals for marketed devices
• Assist in the review of change requests for adequacy of supporting data and to determine necessity of reporting to regulatory authorities
• Travel, as necessary, to support projects.

Regulatory Scientist – iMRI Division

• Define project requirements by identifying project milestones, phases, and elements; form project team
• Create and maintain IT project plans which communicate tasks, milestone dates, status, and resource allocation
• Monitor project progress by tracking activity, identifying problems, and recommending actions
• Prepare and publish progress reports by collecting, analyzing, and summarizing information and trends
• Evaluate initial and additional task requests
• Interface and communicate with staff on all levels of the company
• Act as a liaison with outside vendors as needed
• Utilize software life-cycle methodology
• Coordinate delivery of development and production releases which meet quality assurance standards
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization
• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision
• Ability to remain calm and receptive in fast paced situations
• Strong analytical and problem solving skills
• Good communication and interpersonal skills
• Proficiency in Microsoft suite of software tools
• Must maintain company quality and quantity standards
• Must have effective oral and written communication skills
• Performs work independently.
• Considered a high-level specialist who regularly interacts and works with senior management.
• Uses advanced techniques, theories, and processes to complete work.

Director

• Direct and maintain a scalable, global structure for PMS & CE ensuring clear communication and alignment with regional regulatory needs and business objectives.
• Develop and lead strategic vision and objectives for the global PMS & CE team, ensuring alignment with overall corporate goals, regulatory requirements, and operational excellence initiatives.
• Collaborate closely with global functional leadership to ensure local market needs are integrated into global strategies.
• Provide leadership and mentorship and technical expertise to a diverse, geographically dispersed PMS and CE team, ensuring alignment with global standards and regional needs.
• Oversee and manage PMS & CE budgets, including cost tracking, and strategic planning to support global operational priorities.
• Oversee and ensure that all PMS & CE activities comply with applicable regulations, including FDA (21 CFR Part 801, 21 CFR Part 820), EU MDR/IVDR (Annex I, II), and regional requirements across APAC, LATAM, and MEA.
• Proactively monitor regulatory changes and lead updates to PMS & CE processes to maintain compliance.
• Drive adherence to relevant Quality Management Systems and Business Processes, promoting a culture of quality and organizational effectiveness.
• Engage effectively with stakeholders across all levels of the global organization, including regional regulatory agencies, to foster strategic relationships, influence policy, and ensure compliance.
• Lead cross-functional collaboration to optimize PMS & CE processes.
• Foster a high-performance culture focused on talent development, succession planning, and continuous improvement.
• Establish and maintain global best practices, standardized policies, and/or procedural controls as needed to ensure consistency, accuracy and compliance of PMS & CE work outputs and systems.
• Balance standardization with regional flexibility where necessary.
• Champion a continuous improvement culture by leading initiatives that leverage AI and digital tools, automation, and innovate processes to enhance efficiency, accuracy and compliance in PMS & CE activities.
• Lead initiatives for risk mitigation and proactive adaptation of PMS & CE strategies at a global level including PMS /CE requirements or standards, audit findings.
• Ensure PMS & CE team members possess the requisite technical skills, experience, and training to perform their work.
• Provide strategic recommendations for workforce planning and contribute significantly to employee related decisions and development initiatives.
• Foster and maintain a positive, inclusive and productive work environment aligned with Cook’s culture and values.

Director, Post-Market Surveillance, Clinical Evaluation

Human Resources

• Partners across functions to deliver value-added service to leadership and employees that reflects the business objectives of the organization, developing strategic relationships with internal and external stakeholders
• Supports employees on human resource matters or queries they may have and facilitates actions to resolve these in a timely manner
• Builds strong relationships based on trust with employees and leaders throughout their customer teams
• Partners with Business Leaders in developing team plans to support the business strategy
• Coaches and empowers leaders during the entire employee lifecycle, regarding HR matters/challenges and facilitates effective and proactive decision-making to ensure solutions are realistic, fair, timely, consistent, transparent, and effective
• Provides input in design and development of company-wide HR initiatives and programs to ensure alignment with business requirements
• Leads HR Functional Projects
• Manages and resolves complex employee relations matters. Conducts effective, thorough, and objective investigations where required
• Assists in developing, implementing, and administrating HR policies/procedures, ensuring compliance with relevant statutory legislation and industry best practices
• Trains and mentors HR Generalists as required
• Collaborates with other HR team members locally and across the organization globally
• Collects and analyzes employment data for recommendations to the management team, maintaining records as needed and providing HR Leadership with new HR strategy proposals
• May manage the entire recruitment and selection process in line with business needs, continually looking to introduce improvements where possible
• Provides day-to-day performance management guidance to leadership (e.g., coaching, counseling, career development, disciplinary actions)
• Provides guidance and input on business unit restructures, workforce planning, and succession planning

Human Resources Business Partner

• Serves as the strategic leader responsible for defining and driving the marketing vision for a medical device division across the full product lifecycle
• Ensures that marketing strategies directly support business growth, product adoption, competitive differentiation, and brand strength while remaining aligned with corporate objectives and regulatory expectations
• Collaborates with division leadership to establish business strategy and ensure alignment with corporate brand strategy
• Drives cross-functional marketing collaboration with the division and with key stakeholders across the company
• Works with marketing program and specialty leaders to identify and manage priorities and resources (people, time and money)

Director, Division Marketing – Vascular

Designer

• Lead and manage the Design Assurance Engineering team, including workload management, coaching, and development of team members.
• Act as a liaison with company leadership, representing Design Assurance interests.
• Provide guidance and mentorship to NPD teams on Cook Medical’s global Design Controls, Process Development, and Risk Management policies and systems.
• Participate directly in new product development projects, contributing to design reviews and project deliverables.
• Drive the development, deployment, and training of global Design Controls, Process Development, and Risk Management policies.
• Maintain a comprehensive understanding of Cook Medical’s design and development policies, standards, and applicable regulations.
• Ensure all quality, regulatory, compliance, and product-specific requirements are met within scope.
• Foster employee growth through mentorship, training, and feedback.
• Collaborate with HR on recruiting and hiring efforts.
• Establish and monitor team goals to meet quality assurance objectives.

Manager, Design Assurance

Product Manager

• Lead Division product management to provide global direction, prioritization, and alignment across portfolios, while accommodating for local and regional regulations and needs and adapting to market shifts
• Work closely with other leaders within the Division, company Functions, and Operational Units to develop, implement, and execute the Division product strategy and ensure consistency in priorities, processes, and structure
• Chair divisional portfolio reviews and stage gates; set and manage decision criteria for prioritization and resource allocation
• Set and monitor key performance indicators (KPIs) to evaluate and improve the strategy for Division portfolios and also ensure sustained business growth and operational excellence
• Act and resolve issues and gaps quickly and effectively
• Lead efforts for continuous improvement and as needed change management
• Govern product management activities from feasibility through stage gate, commercialization and launch, post-market support, and retirement
• Ensure compliance with global quality and regulatory requirements
• Lead and support divisional responses to planned/unplanned product events, such as launches, backorders, recalls
• Consistently collaborate with cross-functional leadership and teams to establish, measure and meet business plan goals for each region and portfolio
• Empower product management directors and managers to allocate resources appropriately per specialty and customer needs in alignment with overall portfolio’s strategy
• Establish and maintain strong team communication through regular interactions and meetings, and ensure the team is aware of division and company mission, vision, purpose, and business strategy and overall company status and news
• Provide ongoing coaching, mentoring, and feedback, both formally through the performance management process and informally through daily discussions and interactions, while recognizing employees for their contributions
• Ensure that roles and responsibilities, performance expectations, and training requirements are developed, clearly documented, and communicated to each employee
• Cultivate a safe, secure, and supportive environment where employees can thrive, and morale is maintained
• Collaborate with HR to proactively create and implement effective and inclusive succession planning
• Collaborate with HR in the process of hiring, developing, and retaining a high performing, diverse workforce
• Responsible for performance and wage reviews for team members
• Identify and develop current and future leadership team

Senior Director, Product Management, MedSurg Division

• Serves as the strategic leader responsible for defining and driving the marketing vision for a medical device division across the full product lifecycle
• Ensures that marketing strategies directly support business growth, product adoption, competitive differentiation, and brand strength while remaining aligned with corporate objectives and regulatory expectations
• Collaborates with division leadership to establish business strategy and ensures alignment with corporate brand strategy
• Drives cross-functional marketing collaboration with the division and with key stakeholders across the company
• Proactively works on marketing alignment with customer facing leadership
• Works with marketing program and specialty leaders to identify and manage priorities and resources (people, time and money)

Director, Division Marketing

Engineer

• Ensure new or modified asset information is properly transferred into Maintenance and Calibration systems.
• Define and create technical specifications for a wide variety of projects.
• Read and comprehend blueprints, specifications and sketches and develop/modify CAD drawing for facility or systems.
• Write and modify facility/system documents and procedures.
• Lead/manage in planning, documenting, commissioning, and start-up of new and modified facilities and system installs/upgrades.
• Translate project plans into coherent, credible, realistic project schedules and manage the project.
• Understand complex systems and be able to identify potential areas of improvement.
• PLC interface and configuration/trouble shooting of such equipment.
• Work hands-on with critical equipment/systems.
• Contribute to transforming traditional systems into highly efficient automated environments.
• Play a pivotal role in developing automation strategies that drive sustainability and cost savings.
• Design, integrate, and implement advanced building control systems using Allen Bradley, Modbus, DeviceNet, BACnet, Niagara 4, etc.
• Support the administration of the Building Management System, which monitors critical building utilities.
• Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
• Prepare and maintain accurate documentation consistent with the requirements of pertinent regulations and Cook’s Quality Management System where applicable.
• Maintain all training requirements for the position, while seeking out opportunities for continuous development and growth.

Facilities Engineer

• Collaborate in a team of engineers focused on design, development, and implementation of new processes and test methods required for the development and manufacture of new device designs.
• Execute methods needed for efficient and effective process and test method development (design for manufacturing/assembly, process validation, process capability, lean manufacturing, equipment selection and qualification, and specification development).
• Ensure that a risk based approach is applied during the development, implementation, and validation of all processes and test methods.
• Responsible for process documentation (PFMEA’s, Validation Plans, Production Instructions, Drawings etc.) associated with new production processes.
• Liaise with new product introduction team and production engineering for process engineering layout plans and implementation in relation to new processes and production lines.
• Collaborate with R&D team, Operations, and Manufacturing Engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D engineering project / objective.
• Compare costs and benefits when determining manufacture of product in-house or supplier selection.
• Define, identify, procure, and qualify new equipment for manufacturing processes and test methods.
• Ability to complete projects within specific time lines, costs, and meeting performance expectations.
• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.
• Maintain regular and punctual attendance.
• Must have effective oral, written and presentation communication skills.
• Ability to work in collaborative and independent work situations and environments with minimal supervision.