Location: San Jose, CA
About:
Currently working with a medical device company dedicated to developing and commercializing breakthrough catheter devices that revolutionize patient care on a Regulatory Head position. In this critical role, you will play a pivotal role in ensuring our breakthrough catheter devices navigate the regulatory pathway efficiently and successfully. You will be responsible for developing and implementing regulatory strategies to obtain market authorization from the FDA, including 510(k) clearances and PMAs.
Responsibilities:
- Lead the regulatory strategy for our catheter device portfolio, with a particular focus on breakthrough devices.
- Manage the preparation and submission of regulatory filings, including 510(k) premarket notifications and PMA applications, ensuring compliance with FDA requirements.
- Oversee communication and interaction with the FDA throughout the regulatory process.
- Interface with cross-functional teams (R&D, Quality, Clinical) to gather necessary regulatory data and documentation.
- Develop and maintain a comprehensive understanding of relevant FDA regulations and guidance documents for catheter devices.
- Stay abreast of regulatory trends and proactively identify potential risks and opportunities.
- Manage and mentor junior members of the Regulatory Affairs team.
Qualifications:
- Minimum of 5 years of experience in medical device regulatory affairs with a focus on catheters.
- Proven track record of successfully obtaining 510(k) clearances and/or PMAs for medical devices.
- In-depth knowledge of FDA regulations (21 CFR 801, 820, etc.) and guidance documents for catheter devices.
- Strong understanding of the regulatory pathway for breakthrough devices.
- Excellent project management, communication, and interpersonal skills.
- Ability to work independently and as part of a cross-functional team.
- Meticulous attention to detail and a strong commitment to quality.
