Regulatory Affairs Program Manager
Regulatory Affairs Program Manager
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Job Description
Primary Function of Position:
Executes the regulatory strategy for obtaining registration approval of Intuitives portfolio according to plan. With limited supervision coordinate with related cross functional teams to compile regulatory documentation for submission to regulatory authorities maintenance of licenses and change management. Evaluates medical device changes determines and executes regulatory strategy and ensures compliance. Leads advocacy effort across applicable product regulations environment management regulations and standards related activities with relevant regulators and Government bodies.
Roles & Responsibilities:
- Main activities Works with cross functional teams and business teams to execute regulatory plans for medical device registrations for India.
- Closely communicate with regulatory agencies and global counterparts to seek resolutions on regulatory issues
- Lead with minimal supervision advocacy efforts to drive effective acceptance and implementation of policy change representations.
- Lead with minimal supervision influencing efforts to enable simplification of requirements and timely license processing.
- Should be knowledgeable and have experience with medical device regulations India including requirements for approval change management and license renewals
- Compiles high quality submissions in compliance with technical requirements from regulatory authorities
- Determines the types of regulatory submissions or internal documentation which are required in situations such as proposed device or regulatory changes
- Interprets regulatory documents and interfaces with internal/external stakeholders for timely approval of products /product changes
- Input submission-tracking information into registration tracking system
- Manage SAP RIM regulatory database
- Supports the evaluation of Advertising and Promotional material for compliance
- Assists and supports other teams in ensuring regulatory compliance
- Report and provide product registration status and results to function head as well as stakeholders within Global & India to help business planning
- Performs other tasks and manages projects as assigned
- Additional activities 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
- Supports Quality Management System activities such as CAPA documentation training management review internal & external audits Field Safety Corrective Actions
Qualifications :
Skills Experience Education & Training:
- A Bachelors or Masters degree in Medical Technology Life Sciences Pharma or similar sciences
- 10 - 12 years of experience in medical devices registration in India and similar markets
- 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
- Excellent skills to work with government and regulators for effective policy shaping and influencing activities to enable business needs.
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.
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
