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Regulatory Post Market Surveillance Training Specialist

Company: H&M Hennes & Mauritz GBC AB
Location: Sunnyvale
Posted on: April 3, 2021

Job Description:

Regulatory Post Market Surveillance Training Specialist At Intuitive, we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. Our mission is our guiding force; our culture is the DNA that makes us unique. As a pioneer in robotic-assisted surgery (RAS), we have been expanding our innovations through technology to help make a difference in the world. For 25 years, human ingenuity has guided our journey to help solve some of healthcare's complex challenges. We believe a great idea can come from anywhere-inclusion and mutual respect are vital to our culture. We value character grounded in integrity, a strong capacity to learn, the energy to get things done, and diverse experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and strive to achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients. Together,--let's--help to advance the world of minimally invasive care.-- Primary Function of Position:
The Regulatory Post Market Surveillance (RPMS) Training Specialist uses their in-depth knowledge of Intuitive products, regulatory regulations and risk assessment to mentor, train and develop new and current RPMS members. Interacts with functional organizations to develop specifications for content of courses. Prepares lesson plans including the method, media and documentation to be presented. Works with cross functional teams (i.e. engineering, technical support, field service) to ensure the course material reflect current product features and processes. Instructs participants in classroom lectures and/or group sessions. Conducts follow up to determine applicability of course material. Roles and Responsibilities:

  • Develop and maintain expertise in the following:
    • Intuitive technology use and troubleshooting--
    • Intuitive technology applications--
    • Proper handling, care and use of Intuitive Instruments and Accessories--
    • Cleaning and sterilization of Intuitive instrumentation
    • Complaint handling processes for cross functional teams (Customer Service, Technical Support, Field Service, Failure Analysis)
    • Training and coaching methodologies/techniques and best practices--
    • Regulatory reporting requirements for Medical Devices (US FDA requirements, EU MDD requirements, etc.)
    • Partner to develop a standardized onboarding curriculum leading to successful core competency development.
    • Work closely with internal cross functional teams to leverage evolving technology training programs.
    • Coordinate and/or conduct training classes on Intuitive products, regulatory regulations, complaint processing and regulatory reporting.
    • Quality review of complaint records to ensure that records are complete and accurate.
    • Quality review of MDR and other regulatory reports to ensure that reports are documented and reported accurately
    • Provide input, guidance, training and mentoring regarding complaint and regulatory reporting across the organization
    • Uncover training needs, utilization barriers and opportunities
    • Other tasks to support the Regulatory Post Market Surveillance team in successful and timely complaint management and regulatory reporting, as needed Skills, Experience, Education, & Training:
      • Minimum Bachelor's degree preferably in Clinical or Health Sciences, Healthcare Management, Engineering, Business Administration, Communications or Education--and minimum 3-5 years of experience with Intuitive Surgical preferred
      • Minimum 3+ years in medical device field, with experience or exposure in the following areas:
        • Experience in U.S. FDA Medical Device Reporting
        • Experience in OUS reporting requirements, including the European Medical Device Directive and vigilance reporting requirements
        • General technical and or clinical medical device knowledge
        • Minimum 3+ years training experience with proven experience providing training on complex topics and/or technology
        • Coaching Skills- demonstrated ability to develop competence in others through structured learning experience and feedback strategies.
        • Master Complexity- demonstrated organizational skills and flexibility within role to handle complex and changing environments.
        • Training Ability- demonstrated commitment to peer training, specifically related to advanced technology within a clinical environment
        • Proven ability to work effectively and drive results as part of a team--
        • Excellent communication (written, verbal) and interpersonal skills with ability to present to varying group sizes--
        • Ability to excel in a high-energy, fast-paced environment
        • Strong project management, planning, decision making and change management skills
        • Willingness to be flexible with work hours
        • Must be self-directed with the ability to work independently with minimal supervision Intuitive is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws. We will consider for--employment qualified--applicants with arrest and conviction records in accordance with fair chance laws.--

Keywords: H&M Hennes & Mauritz GBC AB, Sunnyvale , Regulatory Post Market Surveillance Training Specialist, Other , Sunnyvale, California

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