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Regulatory Post Market Surveillance Instructional Designer

Intuitive

Regulatory Post Market Surveillance Instructional Designer

San Diego, CA
Full Time
Paid
  • Responsibilities

    Job Description

    At Intuitive, we are united behind our mission: 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.

    As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare’s hardest challenges and advance what is possible.

    Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves.

    Passionate people who want to make a difference drive our culture—our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world 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 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 advance the world of minimally invasive care.

    Primary Function of Position:  

    The Regulatory Post Market Surveillance (RPMS) Instructional Designer will be responsible for the design and content development of mission critical learning programs, including but not limited to web-based learning, instructor-led training, blended instruction solutions, and virtual sessions. Development will focus on the clinical/technical aspects of our Intuitive products/service complaint handling and will be developed using programs like Storyline 360, Rise 360, Photoshop, and Microsoft Office. Deliverables such as technical product videos and online learning modules will be integrated into learning management systems and multiple delivery platforms.

    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, PMDA requirements, MFDS requirements, etc.)
    • Project manage all phases of learning projects – analysis, design, development, implementation, & evaluation

    • Proactively communicate task and project status to internal and external stakeholders

    • Participate in needs analysis to determine training gaps within Regulatory Post Market Surveillance

    • Work with Subject Matter Experts (SMEs) to identify and capture learning content

    • Select appropriate training modality

    • Design and develop training content that engages learners and aligns with identified outcomes

    • Collaborate with multimedia team to create or modify media assets to support instructional needs

    • Develop eLearning, videos, instructor led, blended learning, and virtual training curriculums

    • Conduct peer review and Quality Assurance of deliverables

    • Work with project manager to manage deliverables through the document control, translation, implementation, and launch process

    • Design, develop, and conduct assessments and evaluations

    • Participate in process improvement efforts

    • Coordinate and/or conduct training classes on Intuitive products, regulatory regulations, complaint processing and regulatory reporting.

    • 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

  • Qualifications

    Qualifications

    Skills, Experience, Education, & Training:

    • Minimum 3-5 yrs. relevant professional experience

    • Minimum 1-2 yrs. experience in biotech or medical device organization preferred, 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
    • Education Background

      • Curriculum Development or Instructional Design/Technology degree preferred
      • Education degree acceptable
      • Minimum College degree required
    • Comprehensive e-learning and classroom design and facilitation skills

    • Strong knowledge of adult learning theory and its application to learning solutions

    • Excellent written and interpersonal communication skills

    • Experience working with SMEs in a team environment

    • Experience working with a learning management system (LMS)

    • Ability to self-manage multiple development projects and deadlines

    • Software Proficiency Required:

      • Articulate Storyline
      • MS Office (Word, Power-Point, Excel)
      • Adobe Photoshop or similar
    • Software Proficiency Preferred:

      • Adobe Creative Suite (InDesign, After Effects, Photoshop)
      • Storyline Rise 360
      • Smartsheet
    • 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

    Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

    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.

    Additional Information

    Due to the nature of our business and the role, please note that Intuitive and/or your customer(s) may require that you show current proof of vaccination against certain diseases including COVID-19.  Details can vary by role.

    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.