Intuitive Surgical Careers
Regulatory Affairs Manager - India
Primary Location: India---
Position’s Objective & Summary:
Management of regulatory operations, regulatory registrations/filings, post-market surveillance activities across in India
Roles & Responsibilities:
- Ensures compliance of all Intuitive Surgical India activities with the Indian regulation, specifically the Medical Device Rules 2017; guide and influence operational decisions accordingly
- Serves as the Management Representative under the Medical Device Rules 2017 for competent authorities
- Responsible for submission of medical device registration dossiers compiled by International Office and according to the Medical Devices Rules 2017
- Coordinates and monitors quality, completeness and timeliness of complaint investigations, medical device vigilance reporting and Field Safety Corrective Actions execution and closure to Indian authorities according to corporate processes. Responds to inquiries by regulatory bodies.
- Works with the Indian Ministry of Health, other Competent Authorities and manufacturer associations to ensure that compliance interpretations are obtained, understood and appropriately communicated and documented in internal procedures.
- Maintains a constructive relationship with health authorities through frequent and transparent dialogue
- Implements and supports Quality Management System activities such as CAPA, documentation, training, management review, audit
- Other regulatory tasks and projects may be assigned as necessary
Required Knowledge, Skills, and Experience:
- A Bachelor, Engineering or Master’s degree in medical technology, life sciences or similar (or equivalent work experience in similar function)
- At least 5 years experience in medical device industry operating according to US or EU regulation.
- Excellent interpersonal skills, demonstrated ability to work with others in international team environment;
- Ability to work autonomously and exercise daily judgment based on above regulatory knowledge.
- Demonstrated organizational and planning skills, including action oriented, focused urgency and driving for results
- Excellent influential communication skills, over the telephone, in person, and in writing.
- Orientation for work result details, with emphasis on accuracy and completeness
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook)
Preferred Knowledge, Skills, and Experience:
- Regulatory Affairs Certification (RAC) is a plus
- Knowledge of the Indian Medical Device Rules 2017