Cook Group

Compliance

• 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

Project Manager

• 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

Regulatory Scientist – iMRI Division

Project Manager

Director, Post-Market Surveillance, Clinical Evaluation

Human Resources Business Partner