Regulatory Affairs Associate

Job Description

**Job Title**: Regulatory Affairs Associate
**Department**: Regulatory Affairs and Quality Compliance
**Position at**: Bangalore

**Position’s Objective & Summary**:
Self-starter, executes the Regulatory strategy for obtaining registration approval of the company portfolio, according to plan. With limited supervision, coordinates and compiles regulatory documentation for submission to regulatory authorities and maintenance of Approvals / Licenses with all relevant regulators, like CDSCO, State FDA, BIS, MEITY, WPC, and any other as requried. Coordinates for evaluation of medical device changes, determining and executing registration strategy and ensuring compliance.

**Roles & Responsibilities**:
Main activities
- Executes regulatory plan for medical devices registrations in Indian markets, with all relevant regulatory authorities, Ministry of Health, MEITY, BIS, WPC, MOEFCC as required.
- Should be knowledgeable and have experience with the medical device related regulations and its requirements for an approval, change management and maintenance of approval:

- Medical device approvals from CDSCO and State FDAs
- Compulsory registration of IT and Electronics as defined by BIS / MEITY
- Wireless Approvals as per WPC
- Additionally, Software as Medical device, Refurbished medical device requirements
- Plans product registration activities, according to Regulatory strategy
- Provides training and knowledge on the product registration requirements to relevant stakeholders across the globe
- Develops processes and documented procedures to map out the product registration plan.
- Compile high quality submissions in compliance with technical requirements from regulatory authorities.
- Determines the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes, regulatory changes.
- Interprets regulatory documents and interfaces with internal Stakeholders for timely approval of products /product changes.
- Input submission-tracking information into registration tracking system.
- Coordinate submission activities among internal Regulatory functions, external Regulatory authorities and online portal submission stakeholder.
- Supports the evaluation of Advertising and Promotional material for compliance.
- Supports the Quality Assurance function by ensuring compliance of activities with current internal and external requirements.
- Assists and supports other teams in ensuring regulatory compliance.
- Performs other tasks and manages projects as assigned.

**Additional activities**:

- Supports that company procedures, processes and documentation meet the required guidelines for maintaining compliance to the Quality Management System, ISO 13485 and other applicable regulations
- Supports Quality Management System activities such as CAPA, documentation, training, management review, internal & external audits, Field Safety Corrective Actions
- Acts independently to determine and coordinate methods and procedures on new assignments and works in teams to install or improve related processes

**Required Knowledge, Skills, and Experience**:

- A Bachelor’s or Master’s degree in medical technology, life sciences, Pharma or similar sciences
- 8-10 years of significant experience in similar function out of which a mandatory of 5-7 years, with proven experience in medical devices registration in India
- Proven experience in interacting and working with CDSCO and other agencies
- Computer literacy (PC, Microsoft Word/Excel/PowerPoint, Outlook

**Preferred Knowledge, Skills, and Experience**:

- Knowledge of Quality Management System requirements to ISO 13485 required and broad understanding of what it takes to work in a regulated environment, Environment regulations and other related regulations
- 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
- Orientation for detail work product, with emphasis on accuracy and completeness
- Ability to be effective in complex projects with ambiguity and/or rapid change
- Ability to handle multiple tasks and to prioritize and schedule work to meet reporting or other deadlines
- Good team skills with ability to collaborate, influence and lead others
- Excellent interpersonal skills, ability to work with customers and authorities