Medtronic
Principal MDR - Vigilance Specialist
Medtronic, Los Angeles, California, United States, 90079
Overview
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This role is with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. We fuse technology and research for groundbreaking solutions in healthcare. From less-invasive surgery to the world’s smallest pacemaker, our technology transforms lives. Key Responsibilities
Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for extraction of ADE data and integrate data to create a unified database aligned with ADE standardization and internalization, ensuring accuracy and quality of safety summaries. Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. Lead or leverage cross-functional teams to evaluate, develop and manage projects for key business processes. Oversee and manage the operational aspects of ongoing projects and serve as liaison between project team and stakeholders. Assess project issues and support the project team in developing resolutions to meet goals and objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation of regulations. Minimum Requirements
Bachelor’s Degree with 7+ years of experience in Quality and/or Regulatory, including direct experience in MDR/vigilance systems implementation. OR Advanced degree with 5+ years of relevant experience in the same areas. Nice to Have
10+ years' experience working with CAPA, Management Review, Change Control and Audit processes Experience with TrackWise software Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc. Experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques Experience with quality tools and process improvement techniques Experience reviewing technical documentation Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team Strong Regulatory Compliance experience – understanding, interpreting and implementing Regulatory changes into policies/processes Excellent verbal, written and presentation communication skills Proven ability to build and facilitate strong, productive working relationships with cross-functional and customer contacts Program management experience in regulated industries Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity Experience in leading within matrix organizations requiring strong influence management skills Change agent — willingness and ability to lead and institute change Influence management skills; ability to work with all levels in a matrix environment Excellent communication and interpersonal skills with ability to succinctly communicate to management and staff Business acumen and ability to act from a “best for the business” perspective Results oriented with strong sense of urgency Strong analytical, planning, organization and time management skills to develop and execute programs and budgets Effective decision-making with ability to balance needs across departments Makes timely decisions in the face of risk and uncertainty On-site Requirement
You will be required to work on-site at our Northridge, CA location a minimum of 3 days per week. Hybrid work arrangements are subject to change due to business needs. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. The base salary range for U.S. locations is $129,600.00 - $194,400.00. Eligible for the Medtronic Incentive Plan (MIP). Benefits include health, dental, vision, 401(k) with employer match, paid time off, holidays, and more. Details vary by location. Equal Opportunity
Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. References to EEO policy and Fair Chance Act are included in the original description.
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At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This role is with Medtronic's Diabetes business. Medtronic has announced its intention to separate the Diabetes division to promote future growth and innovation within the business and reallocate investments and resources across Medtronic, subject to applicable information and consultation requirements. This separation provides our team with a bold opportunity to unleash our potential, enabling us to operate with greater speed and agility. As a separate entity, we anticipate leveraging increased investments to drive meaningful innovation and enhance our impact on patient care. We fuse technology and research for groundbreaking solutions in healthcare. From less-invasive surgery to the world’s smallest pacemaker, our technology transforms lives. Key Responsibilities
Ensure complete and accurate maintenance and reporting of Medical Device Reports (MDRs), Adverse Drug Experience (ADE) data or adverse reaction data as required by regulatory agencies. Review and analyze clinical databases for extraction of ADE data and integrate data to create a unified database aligned with ADE standardization and internalization, ensuring accuracy and quality of safety summaries. Act as a liaison internally and with external collaborators to develop programs and processes to meet regulatory reporting requirements. Lead or leverage cross-functional teams to evaluate, develop and manage projects for key business processes. Oversee and manage the operational aspects of ongoing projects and serve as liaison between project team and stakeholders. Assess project issues and support the project team in developing resolutions to meet goals and objectives. Understand current and upcoming Medical Device Reporting (MDRs) and EU Vigilance Reporting requirements by regulatory bodies and ensure adequate implementation of regulations. Minimum Requirements
Bachelor’s Degree with 7+ years of experience in Quality and/or Regulatory, including direct experience in MDR/vigilance systems implementation. OR Advanced degree with 5+ years of relevant experience in the same areas. Nice to Have
10+ years' experience working with CAPA, Management Review, Change Control and Audit processes Experience with TrackWise software Working knowledge of 21CFR 820, 806, 803, Part 11, Part 4; ANVISA, TGA, Health Canada, EU, China & Japan regulations; ISO 13485, MDSAP, etc. Experience with effective root cause investigation, corrective and preventive action planning, execution and verification of effectiveness techniques Experience with quality tools and process improvement techniques Experience reviewing technical documentation Demonstrated ability to collaborate and influence in a matrixed environment and to work effectively with in-house functional team Strong Regulatory Compliance experience – understanding, interpreting and implementing Regulatory changes into policies/processes Excellent verbal, written and presentation communication skills Proven ability to build and facilitate strong, productive working relationships with cross-functional and customer contacts Program management experience in regulated industries Experience devising and implementing streamlined processes and strategic programs to improve efficiency, timeliness, and productivity Experience in leading within matrix organizations requiring strong influence management skills Change agent — willingness and ability to lead and institute change Influence management skills; ability to work with all levels in a matrix environment Excellent communication and interpersonal skills with ability to succinctly communicate to management and staff Business acumen and ability to act from a “best for the business” perspective Results oriented with strong sense of urgency Strong analytical, planning, organization and time management skills to develop and execute programs and budgets Effective decision-making with ability to balance needs across departments Makes timely decisions in the face of risk and uncertainty On-site Requirement
You will be required to work on-site at our Northridge, CA location a minimum of 3 days per week. Hybrid work arrangements are subject to change due to business needs. Benefits & Compensation
Medtronic offers a competitive salary and flexible benefits package. The base salary range for U.S. locations is $129,600.00 - $194,400.00. Eligible for the Medtronic Incentive Plan (MIP). Benefits include health, dental, vision, 401(k) with employer match, paid time off, holidays, and more. Details vary by location. Equal Opportunity
Medtronic is an equal employment opportunity employer. We provide reasonable accommodations for qualified individuals with disabilities. References to EEO policy and Fair Chance Act are included in the original description.
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