Director of Regulatory Affairs

At Intuitive Surgical, we are seeking a highly experienced and motivated Director of Regulatory Affairs to join our dynamic team. Our company is a global leader in developing and manufacturing innovative medical devices, and we are looking for a skilled individual to lead our regulatory affairs department. This is a unique opportunity to be part of a cutting-edge organization that is revolutionizing the healthcare industry. As the Director of Regulatory Affairs, you will play a crucial role in ensuring our products meet all regulatory requirements and are cleared for market entry. We are looking for a driven and detail-oriented individual with a deep understanding of regulatory processes and strong leadership skills. If you are passionate about making a positive impact on patient care and have the qualifications we are looking for, we would love to hear from you.

1. Develop and implement regulatory strategies to ensure compliance with global regulatory requirements for medical devices.
2. Lead and manage the regulatory affairs team, providing guidance, mentorship, and support to ensure the team's success.
3. Develop and maintain strong relationships with regulatory agencies, key stakeholders, and industry partners to stay current on regulatory changes and updates.
4. Oversee the preparation and submission of regulatory documents and reports to regulatory authorities, including 510(k)s, PMA supplements, and international submissions.
5. Collaborate with cross-functional teams to ensure timely and accurate completion of all regulatory activities, including product development, clinical trials, and quality assurance.
6. Conduct regulatory risk assessments and advise on potential risks and mitigation strategies.
7. Monitor and interpret changes in regulations and communicate their impact on the company's products and processes.
8. Ensure compliance with all applicable laws, regulations, and standards, including FDA, ISO, and other global requirements.
9. Manage the review and approval of labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
10. Participate in product development teams to provide regulatory guidance and ensure regulatory requirements are incorporated into product design and development.
11. Provide regulatory support and guidance to other departments, including quality, clinical, and marketing.
12. Prepare and present regulatory updates and reports to senior management and other stakeholders.
13. Manage relationships with third-party consultants and contractors to support regulatory activities.
14. Continuously review and improve regulatory processes and procedures to ensure efficiency and effectiveness.
15. Keep abreast of industry trends and best practices in regulatory affairs and contribute to the development and implementation of company-wide strategies.

According to JobzMall, the average salary range for a Director of Regulatory Affairs in Sunnyvale, CA, USA is $170,000 - $200,000 per year. This can vary depending on the specific company, industry, and level of experience of the director.

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.