Intuitive Hiring for Project Manager, Regulatory Operations Job at Sunnyvale, CA Full Time

Company 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.

Job Description

Primary Function of Position:

As the Project Manager, Regulatory Operations, you will primarily be responsible for Corporate Regulatory Operations – Projects, Processes and Tools. Act as the corporate liaison between internal cross functional teams as well as global regulatory counterparts in establishing, and streamlining cross functional and global processes, supporting global registrations and roll outs.

Roles & Responsibilities:

• 
  Establish corporate processes, tools and best practices to streamline global product registrations and roll outs
  
• Work with cross functional teams including manufacturing, business operations, project management, labeling, quality, global regulatory etc.
• Develop, establish and improve processes related to product release including design development, change control, regulatory assessments and lifecycle management
• Develop process improvement initiatives to accelerate and simplify global regulatory product registrations. Establish STED and other such tools to optimize global submission timelines, leverage Design History File, US submissions and EU Technical Documentation.
• Monitor and trend processes to identify issues and improve hand-offs. Proactively identify areas of improvement. Bring benchmarked and best in class practices for efficient global product launches and change management.
• Lead and/or support efforts to automate processes, centralize regulatory and product data to support registrations and minimize manual transactions and documentation updates.
• Team member and/or lead for CAPAs and Audit findings that require regulatory support.

Act as the Regulatory SME for Regulatory Standards Assessment

• Determine impact of standard, changes in standard and provide regulatory guidance and interpretation
• Update procedures, process and regulatory deliverables as needed.

Directly manage and oversee team to support regulatory operational activities including

• FDA establishment and facility registrations, device listing management, CA state licenses
• Annual laser reports
• Review of training materials
• Audit support for regulatory deliverables, process and data
• Import/export needs for regulatory registration and clearance information
• Additional overall ad-hoc support for regulatory teams

Perform managerial, leadership and employee/team development responsibilities

• Manage priority, timelines and resources
• Build a strong and growing team by recruiting, mentoring and training to meet the growing needs of the business

Qualifications

Skills, Experience, Education, & Training:

• Minimum B.S. or higher in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, or Pharmacy preferred.
• Non-technical degree with equivalent complex medical device experience acceptable
• Minimum of 8 years’ experience working in a medical device company in a regulatory function
• Minimum of 2 years’ experience managing and leading teams
• Direct experience with US FDA and EU MDD/MDR regulations. Overall understanding of global medical device regulations QSRs and ISO standards.
• Thorough knowledge of product development process and design and change control is required
• Ability to problem solve while being detailed oriented is critical
• Strong verbal and written communication skills
• Ability to summarize and present key information to high level leaders
• Ability to work with cross functional project teams and understand complex products
• Ability to work in a fast-paced environment and handle multiple projects simultaneously

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.

Shift : Day

Travel : None

Travel Requirements:None Shift:Day