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Senior Regulatory Affairs Specialist

Company: Intuitive
Location: Sunnyvale
Posted on: January 13, 2022

Job Description:

Senior Regulatory Affairs Specialist - 215086
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:Regulatory registrations/filings in the Indirect EMEIA region and Regulatory operations support.Roles & Responsibilities:

  • Plans, organizes, prepares and maintains regulatory registrations and filings that are supported by distributors
  • Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
  • Monitors regulatory changes in indirect markets to ensure compliance to local regulations are met and partner with distributors to align
  • Interprets regulatory documents and interfaces either directly with the regulatory body or indirectly through a distributor or consultant for timely approval of products /product changes
  • Communicates registration strategy with sales & marketing stakeholders Additional activities
  • Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
  • Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements
  • Assists and supports other employees, teams and field personnel as necessary
  • Performs other tasks and manages projects as assignedSkills, Experience, Education, & Training:Minimum 7+ years of significant experience in similar function
    • Knowledge of emerging market regulations
    • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
    • Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
    • Ability to be effective in complex projects with ambiguity and/or rapid change
    • Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
    • Good team skills with ability to collaborate, influence and lead others
    • Excellent interpersonal skills, ability to work with customers and authorities
    • Orientation for detail work product, with emphasis on accuracy and completeness
    • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plus
    • A Bachelor's or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
    • Strong knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment
    • Fluent in written and spoken English, ideally possessing other language skills
      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.Shift : Shift 1 - DayTravel : Yes, 25 % of the Time#911
      Senior Regulatory Affairs Specialist - 215086
      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:Regulatory registrations/filings in the Indirect EMEIA region and Regulatory operations support.Roles & Responsibilities:
      • Plans, organizes, prepares and maintains regulatory registrations and filings that are supported by distributors
      • Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes
      • Monitors regulatory changes in indirect markets to ensure compliance to local regulations are met and partner with distributors to align
      • Interprets regulatory documents and interfaces either directly with the regulatory body or indirectly through a distributor or consultant for timely approval of products /product changes
      • Communicates registration strategy with sales & marketing stakeholders Additional activities
      • Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes
      • Supports the Regulatory Affairs function by ensuring compliance of activities with current internal and external requirements
      • Assists and supports other employees, teams and field personnel as necessary
      • Performs other tasks and manages projects as assignedSkills, Experience, Education, & Training:Minimum 7+ years of significant experience in similar function
        • Knowledge of emerging market regulations
        • Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices
        • Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
        • Ability to be effective in complex projects with ambiguity and/or rapid change
        • Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
        • Good team skills with ability to collaborate, influence and lead others
        • Excellent interpersonal skills, ability to work with customers and authorities
        • Orientation for detail work product, with emphasis on accuracy and completeness
        • Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile, CRM and SAP a plus
        • A Bachelor's or Master's degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
        • Strong knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment
        • Fluent in written and spoken English, ideally possessing other language skills
          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.Shift : Shift 1 - DayTravel : Yes, 25 % of the Time
          Shift : Shift 1 - DayTravel : Yes, 25 % of the TimeTravel Requirements:Yes, 25 % of the Time Shift:Shift 1 - Day

Keywords: Intuitive, Sunnyvale , Senior Regulatory Affairs Specialist, Other , Sunnyvale, California

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