Director, Post-Market Surveillance and Clinical Evaluation
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Job Location:
Monthly Salary:
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Department:
Job Summary
Overview
The Director of Post-Market Surveillance and Clinical Evaluation leads the global strategy governance and compliance of Post Market Surveillance and Clinical Evaluation activities ensuring accuracy regulatory alignment and continuous improvement across markets through standardized systems and processes. Leads and inspire global teams fostering a culture of collaboration accountability and high performance to ensure consistent delivery of centralized capabilities across all markets.
Responsibilities
- 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 standardised 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 Cooks culture and values.
- Willingness and availability to travel globally on company business.
Qualifications
- Third level Qualification preferably in Science/Engineering is required.
- A minimum of 12 years experience in a regulated industry in a similar role preferred.
- Comprehensive understanding of PMS & CE related requirements and a broad range of all medical device requirements in accordance with regulatory standards - ISO13485 MDD 93/42/EEC EU Medical Device Regulation 2017/745 and FDA QSP 21CFR is required.
- Strong leadership and team management capabilities with demonstrated success in guiding and developing global teams.
- Ability to lead and deliver multiple complex global projects simultaneously within deadlines.
- Ability to develop and maintain strong working relationships with internal and external stakeholders worldwide.
- Adapt to dynamic landscapes and organizational changes with the ability to adjust quickly and effectively in a change-driven environment.
- Excellent problem-solving abilities and the capacity to work effectively both collaboratively and independently in environments with minimal supervision.
- Excellent organizational and planning abilities complemented by keen attention to detail.
- Demonstrated ability to work in a fast-paced high-pressure environment and meet deadlines.
- Collaborative team player with a proven ability to foster trust open communication and effective collaboration across diverse teams and stakeholders.
- Effective communication and interpersonal skills to build relationships across diverse geographies and cultures.
- Self-motivated and proactive with a passion for driving quality and operational excellence.
- Flexibility to work across global time zones as required.
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Required Experience:
Director
Key Skills
- Microsoft Access
- SQL
- Analysis Skills
- Microsoft Powerpoint
- Securities Law
- Data Mining
- Investment Banking
- Market Research
- Microsoft Excel
- Visual Basic
- Bloomberg
- Data Analysis Skills
About Company
Cook Medical is a family-owned medical device company that works with physicians to develop devices that are less invasive for patients.
