Regulatory Affairs and Quality Specialist

Job Description

Job: Regulatory and Quality
Primary Location: India-Bangalore-Bengaluru
Schedule: Full-time
Requisition ID: 200409
Description
Position’s Objective & Summary:
Quality System coordination, Complaint Handling, Adverse Event reporting & Field Safety
Corrective Actions, Regulatory operations support, regulatory registrations/filings,
Roles & Responsibilities:
Main activities
 Implements and supports Quality Management System activities such as Complaint handling,
documentation, CAPA, training, management review, audit
 Ensures that company procedures, processes and documentation meet the required
guidelines for maintaining compliance to the Quality Management System, ISO 13485 and
other applicable regulations
 Coordinates complaint reporting and adverse event reporting for India
 Coordinates execution of Field Safety Corrective Actions in India
 Aligns with the Corporate QMS by working closely with the relevant departments in US
 Collaborates with all functional areas of the business to disseminate QMS best practice
throughout the organization
 Plans, organizes, prepares and maintains regulatory registrations and filings for India
 Determines the types of regulatory submissions or internal documentation that are required
in situations such as proposed device changes
 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
 Supports the Regulatory Affairs function by ensuring compliance of activities with current
internal and external requirements
Additional activities
 Acts independently to determine and coordinate methods and procedures on new
assignments and works in teams to install or improve related processes
 Assists and supports other employees, teams and field personnel as necessary
 Performs other tasks and manages projects as assigned
Preferred Knowledge, Skills, and Experience:
 2-5 years of significant experience in similar function
 Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other
deadlines
 Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook), experience with Agile,
CRM and SAP a plus

Company Description:

Who is Intuitive Surgical? The numbers tell an amazing story. Learn more about our company.

Joining Intuitive Surgical means joining a team dedicated to using technology to benefit patients by improving surgical efficacy and decreasing surgical invasiveness, with patient safety as our highest priority.Qualifications
Required Knowledge, Skills, and Experience:
 A Bachelor’s or Master’s degree in medical technology, life sciences or similar (or equivalent
work experience in similar function)
 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
 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
 Solid knowledge of Quality Management System requirements to ISO 13485 required and
broad understanding of what it takes to work in a regulated environment
 Good knowledge of the Indian Regulatory environment and process
 Fluent in written and spoken English, ideally possessing other language skills for the European
market