Sr. Manager, Regulatory Affairs

Outset Medical, Inc.•San Jose, CA

49d

About The Position

We are seeking a highly skilled and experienced professional to join our Regulatory Affairs team as Sr. Manager, Regulatory Affairs. In this role, you will provide strategic leadership and oversight in all regulatory aspects related to our medical device portfolio. You will collaborate closely with cross-functional teams to develop and execute regulatory strategies that align with business goals and ensure compliance with applicable regulations and standards.

Requirements

Bachelor's degree in a scientific or engineering discipline.
Minimum of 8 years of regulatory affairs experience in the medical device industry.
In-depth knowledge of medical device regulations and standards, such as FDA regulations (21 CFR Part 820) and ISO 13485.
Proven track record of successful regulatory submissions and clearances for medical devices, including 510(k) submissions.
Experience interacting with regulatory agencies, such as the FDA and notified bodies.
Excellent project management skills, with the ability to prioritize and manage multiple projects simultaneously.
Working knowledge for developing a regulatory strategy for SaMD and artificial intelligence (AI) enabled software medical devices in the US.
Strong leadership and communication skills, with the ability to collaborate effectively with cross-functional teams and influence key stakeholders.
Detail-oriented with exceptional analytical and problem-solving abilities.
Regulatory affairs certifications (RAC).

Nice To Haves

Advanced degree (master's or Ph.D.) is preferred.

Responsibilities

Develop and execute regulatory strategies for the successful development, registration, and commercialization of medical devices in the US.
Provide regulatory guidance and expertise to cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Marketing, throughout the product lifecycle.
Assess and interpret regulatory requirements and provide recommendations on product development plans, labeling, human factor study, and clinical trial designs to ensure compliance.
Manage and review regulatory submissions, including 510(k) premarket notifications, 510(k), De-Novo applications, Pre-submissions, and IDEs.
Manage and maintain regulatory documentation, including regulatory files, correspondence with regulatory authorities, and product registrations.
Stay current with evolving regulatory requirements, industry trends, and best practices, and proactively communicate updates and potential impacts to stakeholders.
Coordinate and liaise with regulatory authorities, such as the FDA, notified body, and other regulatory agencies, to facilitate product approvals, clearances, and registrations.
Ensure labeling and advertising materials comply with regulatory requirements and are accurately represented.
Establish and maintain relationships with key stakeholders, industry organizations, and trade associations to stay informed about regulatory changes and best practices.
Train and educate staff on regulatory requirements, procedures, and best practices.