RAQA Specialist

Job Description

Primary Function of Position

The Regulatory Affairs Specialist supports the department by converting/creating the Medical Device Technical Documentation according to the India Medical Device Rules, evaluating medical device changes, determining and executing registration strategy and ensuring compliance of marketing material according to internal processes

Essential Job Duties

• Prepares and submits medical device technical documentation according to India Medical device rules requirements
• Assesses the regulatory impact on the development of new devices or the changes to existing products
• Coordinates registration strategy with sales/marketing stakeholders
• Prepares and submits Medical Device registration dossiers for assigned geographies and ensures accurate records
• Replies regulatory inquiries to key stakeholders (e.g. Customer Service, Contract/Tender, Sales)
• Performs regulatory review of marketing material (e.g. brochures, presentations) for compliance to assigned geographies regulations
• Additional activities
• Supports Quality Management system activities such as CAPA or internal & external audits as needed
• Supports process improvement and implementation of regulatory projects/tools
• Assists and supports other employees, teams and field personnel as necessary
• Other regulatory tasks and projects may be assigned as necessary

#LI-Hybrid

Qualifications

Required Skills and Experience

• Good Knowledge/understanding of the India Medical device regulations, Quality control orders, legal metrology rules, Waste management regulations
• Good knowledge of medical device registration Advertisement and Promotional requirements of India
• General Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
• Experience
• 8-10 years of experience in a medical device regulatory affairs department
• A bachelor’s or master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
• Interpersonal skills
• Ability to translate technical documentation into effective regulatory documentation
• Ability to navigate through technical documentation and independently identify deviations from internal processes
• Demonstrate organizational and planning skills, including action oriented, focus urgency and driving for results
• Demonstrate good interpersonal skills, ability to work with others in international team and cross department environment
• Orientation for work result details, with emphasis on accuracy and completeness
• Fluent in written and spoken English
• Preferred Knowledge, Skills, and Experience:
• US FDA 21 CFR 803/806/820 basic knowledge would be a plus
• ISO13485 requirements and working knowledge on quality management systems

Required Education and Training

• A Bachelor's or Master's degree in Medical Technology, Life Sciences, Pharma or similar sciences
• 5 - 8 years of experience in medical devices registration in ASEAN countries
• Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
• Preferred Knowledge, Skills, and Experience: Knowledge of Quality Management System requirements to ISO 13485 and 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 be effective in 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, ability to collaborate and influence others
• Excellent interpersonal skills, ability to work with customers and authorities

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.

U.S. Export Controls Disclaimer:  In accordance with the U.S. Export Administration Regulations (15 CFR §743.13(b)), some roles at Intuitive Surgical may be subject to U.S. export controls for prospective employees
who are nationals from countries currently on embargo or sanctions status.

Certain information you provide as part of the application will be used for purposes of determining whether Intuitive Surgical will need to (i) obtain an export license from the U.S. Government on your behalf (note: the government’s licensing process can take 3 to 6+ months) or (ii) implement a Technology Control Plan (“TCP”) (note: typically adds 2 weeks to the hiring process).  

For any Intuitive role subject to export controls, final offers are contingent upon obtaining an approved export license and/or an executed TCP prior to the prospective employee’s
start date, which may or may not be flexible, and within a timeframe that does not unreasonably impede the hiring need. If applicable, candidates will be notified and instructed on any requirements for these purposes. 

This position may be filled at a different job level than listed here depending on
business need and/or on the selected candidate’s experience, knowledge and skills.
Compensation will be based primarily on the job level at which the role is filled and the
candidate’s qualifications, consistent with applicable law.