Director Regulatory Affairs - Cardiac
Are you a seasoned regulatory affairs professional with a passion for advancing innovative medical technology? Do you have a strong background in the cardiac space and a desire to impact patient outcomes? Look no further than Intuitive Surgical! As the Director of Regulatory Affairs for our Cardiac division, you will play a pivotal role in ensuring compliance with global regulatory requirements for our cutting-edge robotic surgical systems. We are seeking a dynamic leader with a proven track record in the medical device industry and a deep understanding of cardiac regulations. Join our team and make a difference in the lives of patients worldwide.
- Develop and implement regulatory strategies for the Cardiac division in alignment with global regulatory requirements.
- Monitor and interpret changes in regulatory policies and guidelines related to cardiac medical devices and communicate updates to relevant stakeholders.
- Collaborate with cross-functional teams to ensure regulatory compliance throughout the product development lifecycle.
- Conduct risk assessments and provide guidance on potential regulatory issues.
- Prepare and submit regulatory submissions and documentation to regulatory bodies for product approvals and registrations.
- Maintain and update product registrations and licenses to ensure continued compliance.
- Serve as the primary point of contact for regulatory agencies and participate in regulatory agency meetings and audits.
- Stay abreast of emerging technologies and trends in the cardiac space to inform regulatory strategies.
- Provide guidance and mentorship to team members on regulatory affairs best practices and processes.
- Develop and maintain relationships with key stakeholders, including internal teams, external partners, and regulatory agencies.
- Oversee the review and approval of labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
- Collaborate with Quality Assurance to ensure compliance with quality system regulations.
- Participate in cross-functional meetings to provide regulatory insights and guidance on product development.
- Conduct training sessions for internal teams on regulatory requirements and updates.
- Continuously evaluate and improve regulatory processes and procedures to ensure efficiency and effectiveness.
In-Depth Knowledge Of Cardiac Medical Device Regulations:
The Ideal Candidate Should Possess A Strong Understanding Of The Regulatory Landscape For Cardiac Medical Devices, Including Fda Regulations, Iso Standards, And Other Relevant Guidelines.
Experience In Obtaining Regulatory Approvals:
The Director Of Regulatory Affairs Will Be Responsible For Obtaining And Maintaining Regulatory Approvals For Cardiac Products. Therefore, The Candidate Should Have A Proven Track Record Of Successfully Obtaining Regulatory Clearances And Approvals For Medical Devices.
Strong Leadership And Communication Skills:
As A Director, This Individual Will Be Leading A Team And Working Closely With Cross-Functional Teams Within The Organization. Excellent Leadership And Communication Skills Are Essential For Effectively Managing And Collaborating With Others.
Familiarity With Clinical Trials:
The Candidate Should Have Experience In Managing Clinical Trials For Cardiac Medical Devices, Including The Design, Execution, And Reporting Of Results. This Will Be Critical In Ensuring Regulatory Compliance And Obtaining Approvals.
Strategic Thinking And Problem-Solving Abilities:
The Director Of Regulatory Affairs Will Be Responsible For Developing And Implementing Regulatory Strategies For New Cardiac Products. The Ideal Candidate Should Possess Strong Analytical And Problem-Solving Skills To Navigate Complex Regulatory Requirements And Develop Effective Strategies For Obtaining Approvals.
Risk Management
Product Development
Quality Management
Regulatory compliance
FDA regulations
Interdisciplinary Collaboration
Medical Devices
Project
Clinical Trials
Regulatory Strategy
Global Strategy
Submission Strategy
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
Interpersonal Skills
creativity
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Director Regulatory Affairs - Cardiac in Sunnyvale, CA, USA is between $189,000 and $236,000 per year. However, salaries may vary depending on factors such as the size and type of company, level of experience, and specific job duties.
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Intuitive Surgical Inc. is an American corporation that develops, manufactures and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery, most notably with the da Vinci Surgical System.
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