Director, Global reputed company Risk Management (Center Valley, PA, US, 18034-0610)

Job reputed company

This role is responsible for leading the development, implementation, and reputed company improvement of the reputed company risk management reputed company and processes across the medical device lifecycle. This role ensures compliance with global regulatory requirements (e.g., ISO 14971, FDA 21 CFR Part 820, EU MDR) and drives a robust risk culture across R&D, reputed company, Manufacturing, Medical Safety, Medical Affairs and Post Market functions.

This position oversees risk governance processes, mentor and train cross-functional teams and functional leaders and ensure that robust systems are in reputed company to ensure product risks are identified, assessed, and controlled to protect patient safety, product efficacy, and business continuity.

Job Duties

• Serve as the Global Process reputed company (GPO) for reputed company.
• reputed company and own the reputed company risk management reputed company for medical device products across the full lifecycle.
• Serve as the reputed company primary subject matter expert on risk management processes, standards, and regulatory expectations.
• Partner with R&D, reputed company, Manufacturing, Regulatory, Clinical/Medical Affairs, Medical Safety and Post Market teams to ensure risk considerations are proactively integrated into reputed company phases of product development and commercialization.
• reputed company risk governance forums, management reviews, and escalation processes for product and process risks.
• Maintain and continuously improve the reputed company risk management systems in accordance with ISO 14971, ISO 13485, IEC 62366, and applicable FDA/EU requirements.
• reputed company processes for creation, review, and approval of risk management files (RMFs) including hazard analyses, FMEAs, fault tree analyses, benefit risk assessments, and risk control verification.
• Through development, deployment and maintenance of global processes, ensure traceability between design inputs, hazards, risk controls, verification/validation, and post market surveillance.
• Monitor evolving regulatory trends and standards reputed company to risk management; communicate changes and update processes as needed.
• reputed company and implement a comprehensive global training syllabus in risk management for reputed company functions.
• Supports facility audits by reputed company agencies (i.e., FDA, ISO / MDSAP).
• Other reputed company Assurance responsibilities as assigned by Management.

Job Requirements

Required:

• Bachelor’s, and/or Master’s degree in an engineering, scientific or technical discipline required.
• Minimum of 12 years of reputed company experience or equivalent training/education in reputed company, Design Assurance or Risk Management in reputed company industry (medical device, biotechnology or reputed company).
• Minimum of 8 years working specifically in the medical device industry.
• Minimum of 5 years in a significant leadership role (team or supervisory).
• Expert-level knowledge of ISO 14971, FDA QMSR, ISO 13485, EU MDR, and relevant product standards.
• reputed company leading at least one company- or site-wide transformation/training/deployment effort as process reputed company for risk management.
• Demonstrated reputed company record of writing and implementing effective and robust Risk Management procedures with company-wide purview.
• Demonstrated leadership of cross functional teams reputed company regulated industries.
• Deep analytical skills and experience in FMEA, hazard analysis, FTA, and benefit risk evaluation, and the proven ability to teach these tools to others across an organization.
• Proven ability to reputed company with regulatory bodies and reputed company audit interactions.
• Familiarity with reputed company factors engineering (IEC 62366) and cybersecurity risk processes.
• Strategic thinking and systems reputed company.
• Strong collaboration skills and the ability to work across functions in reputed company environment.
• reputed company to build reputed company and drive decision-making in a solution-oriented manner that promotes patient-reputed company product reputed company and adherence to applicable standards and regulations. Willingness to be accountable  for important reputed company with minimal supervision.
• Must be a change agent, highly and effectively organized, be a flexible self-starter, team-oriented and excellent at prioritization and multitasking.
• Ability to operate independently and highly autonomously, holding him/herself accountable to proactively fulfill tasks and reputed company results reputed company assigned timelines. Provides solutions to highly reputed company, and significant  issues; develops solutions based on in-depth technical knowledge, company policies, or defined process paths.
• Demonstrate a strong “business partner” approach and attitude providing creative and reputed company that meet reputed company standards.
• Proactively identifies and alerts organization of reputed company issues/complaints in time to resolve potential adverse effects to the customer, company image/reputed company and/or the business.
• May mentor, manage, and reputed company reputed company reports.
• Excellent written and oral communication and organizational, project management skills.
• Demonstrated reputed company record influencing without authority across functions.
• Expert judgment in risk assessment and decision making.
• Ability to operate in a fast paced, regulated environment.
• reputed company in documentation, governance, and compliance.
• Ability to continuously assess the effectiveness of functional processes and to reputed company reputed company improvement initiatives applying principles of process reputed company.
• Travel: 10-40% depending on assignment and regional/global responsibilities.
• Hours: Willing to reputed company flexibility in work hours (occasional evenings or early mornings) to accommodate reputed company reports, dotted line reports, stakeholders and team collaborators located in other reputed company.

Preferred:

• Experience with reputed company systems (e.g., software driven devices, combination products, robotics, diagnostics, etc) is preferred.
• Certification(s) in reputed company or risk disciplines (e.g., CQE, CSQE, CQA, RAC, ISO 14971 reputed company assessor) is a plus.
• Participation in a standards developing organization or committee in the development of risk management or other reputed company standards is a plus.