Supply Chain Program Manager developing strategies and plans with a cross - functional team at L3Harris Maritime. Collaborating with various departments to ensure effective execution of supply chain objectives.
About the role
- Senior Program Manager at Medtronic leading post-market surveillance strategies and ensuring patient safety compliance. Collaborating cross-functionally to drive innovation and regulatory excellence.
Responsibilities
- Assess the current Post-Market Surveillance (PMS) processes and develop proactive, safety/compliance driven strategies.
- Monitor and analyze post-market surveillance data, metrics and KPIs (e.g., complaints, adverse events, external signals) to identify risks, trends, and opportunities for process and product improvement.
- Advise Operating Units and enterprise functions regarding post-market surveillance processes and activities in collaboration with Quality, Regulatory Affairs and Medical Safety teams.
- Support internal and external audits related to PMS activities, serving as the subject matter expert (SME) and ensuring alignment with global regulatory standards.
- Identify opportunities to improve seamless integration of PMS with risk management frameworks, including methodologies to ensure the life-cycle processes, activities and documentation alignment and integration.
- Collaborate with Risk Management Center of Expertise (COE) experts and cross-functional teams to proactively assess and mitigate risks associated with Medtronic products, ensuring patient-centric decision-making.
- Drive initiatives to position Medtronic as a best-in-class organization in PMS by identifying and implementing innovative tools, technologies (e.g., Digital, AI/ML), and methodologies.
- Proactively address gaps in systems and processes, ensuring alignment with evolving regulatory expectations and industry standards.
- Establish and optimize meaningful KPIs to measure PMS effectiveness, performance and efficiency, ensuring actionable insights and continuous improvement.
- Maintain and continuously improve quality system procedures related to PMS to meet evolving regulatory requirements and industry best practices.
- Provide strategic guidance and leadership to support PMS-related initiatives across multiple business units, driving safety and compliance-oriented solutions.
- Represent the PMS COE in cross-functional and executive meetings, ensuring alignment with organizational goals and regulatory priorities.
- Promote a culture of collaboration, accountability, and excellence.
Requirements
- Bachelor's degree required
- Minimum 7 years of experience in post-market surveillance, risk management, CAPA, FCA (recalls), and complaints handling within the medical device industry or other regulated health care industries.
- OR advanced degree with a minimum of 5 years of experience in post-market surveillance, risk management, CAPA, FCA (recalls), and complaints handling within the medical device industry or other regulated health care industries.
- Bachelor’s degree in Engineering, Life Sciences, or related STEM field (Nice to Have)
- Advanced degree preferred (e.g., MS, or PhD) in STEM fields (Nice to Have)
- Proven track record of establishing and improving PMS processes and systems with a focus on patient safety.
- Strong understanding of EU MDR, FDA, and other global regulatory requirements.
- Strong working knowledge of global regulations (e.g., FDA’s 21 CFR 820, EU MDR and other global regulations) and international standards (e.g., ISO 13485 and ISO 14971).
- Exceptional leadership, communication, analytical, influencing and interpersonal skills.
- Strategic thinker with the ability to balance visionary goals with realistic, practical execution.
- Action-driven and focused on delivering measurable results.
- Experience leading complex projects/programs
- Experience with SPC, CAPA, NCMR, PDP processes
- Effective planning and organization skills including the proven ability to work against multiple objectives simultaneously.
- Ability to establish and maintain a trusted role with the various stakeholders in coordinating multiple functions across the organization.
- PMP Certification (Nice to Have)
- Manufacturing Experience (Nice to Have)
- Green Belt (Nice to Have)
- Six Sigma/DRM Training/Certification (Nice to Have)
- Demonstrated working knowledge of process validation, statistical methods, risk management
Benefits
- Health, Dental and vision insurance
- Health Savings Account
- Healthcare Flexible Spending Account
- Life insurance
- Long-term disability leave
- Dependent daycare spending account
- Tuition assistance/reimbursement
- Simple Steps (global well-being program)
- Incentive plans
- 401(k) plan plus employer contribution and match
- Short-term disability
- Paid time off
- Paid holidays
- Employee Stock Purchase Plan
- Employee Assistance Program
- Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
- Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
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