Job Description

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.



Position\'s Objective & Summary:

• Execute the regulatory strategy for obtaining registration approval of Intuitive\'s portfolio according to plan. With limited supervision, coordinate with Distributor RA to compile regulatory documentation for submission to regulatory authorities, maintenance of licenses and change management.
• Evaluate medical device changes, determine and execute regulatory strategy and ensure compliance.
• Ensure that company procedures, processes and documentation meet the required guidelines for maintaining compliance with the Quality Management System, ISO 13485 and other applicable regulations.

Roles & Responsibilities:

• Work with Distributor RA to execute regulatory plans for medical device registrations in APAC indirect markets.
• Communicate with the Distributor on regulatory agencies and global counterparts to seek resolutions on regulatory issues.
• Knowledge and experience with medical device regulations in ASEAN countries, including requirements for approval, change management and license renewals.
• Compile high-quality submissions in compliance with technical requirements from regulatory authorities.
• Determine the types of regulatory submissions or internal documentation required in situations such as proposed devices or regulatory changes.
• Interpret regulatory documents and interface with internal/external stakeholders for timely approval of products /product changes.
• Input submission-tracking information into the registration tracking system. Manage SAP and RIM regulatory database.
• Support the evaluation of Advertising and Promotional material for compliance.
• Assist and support other teams in ensuring regulatory compliance.
• Report and provide product registration status and results to function head as well as stakeholders within Global & APAC indirect markets to help business planning.
• Support Quality Management System activities such as CAPA, documentation, training, management review, internal & external audits, and Field Safety Corrective Actions.
• Perform other tasks and manages projects as assigned.

Qualifications

Required Knowledge, Skills, and Experience:

• Minimum bachelor\'s or Master\'s Degree in Medical Technology, Life Sciences, Pharma or similar sciences.
• At least 8 - 10 years of experience in the medical devices industry in ASEAN countries.
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook).
• People management experience (internal/external stakeholders).
• Ability to travel at least 20%.

Preferred Knowledge, Skills, and Experience:

• Knowledge of Quality Management System requirements to ISO 13485 and a broad understanding of what it takes to work in a regulated environment.
• Ability to exercise independent judgment and discretion within a broadly defined range of policies and practices.
• Organizational and planning skills, including action orientation, focused urgency and driving for results.
• Detail-oriented.
• Ability to effectively manage complex projects with ambiguity and/or rapid change.
• Ability to multi-task, prioritize and schedule work to meet reporting or other deadlines.
• Good team player with the ability to collaborate and influence others.
• Excellent interpersonal skills and ability to work with customers and authorities.
• Experience with Agile system.

Additional Information

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.

Intuitive Surgical