Sr. Manager, Regulatory Affairs at Outset Medical

San Jose, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, Dialysis, HealthcareIndustries

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

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

Skills

Regulatory Affairs

Medical Devices

FDA

Regulatory Strategy

Product Registration

Compliance

Quality Assurance

Clinical Affairs

R&D

Outset Medical

Dialysis treatment solutions and training programs

About Outset Medical

Outset Medical focuses on improving dialysis treatment in the healthcare sector. Their main product, Tablo, is a system that simplifies the dialysis process by integrating with electronic medical record (EMR) platforms, allowing for better management of patient data with real-time updates and alerts. This helps streamline workflows from charting to billing. In addition to Tablo, Outset Medical provides educational programs and hands-on training for dialysis professionals, including a Vascular Access Program that enhances staff skills in cannulation and vascular access management. They also offer a Bridge Program to assist facilities transitioning to in-house dialysis services by providing experienced dialysis nurses for training and support. Outset Medical aims to enhance the quality of care for dialysis patients across various settings, including hospitals, outpatient clinics, and home care.

San Jose, CaliforniaHeadquarters

2010Year Founded

$542.8MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

501-1,000Employees

Benefits

Medical, dental, & vision

Life Insurance/AD&D

FSA & HSA

401k

Parental leave

Pet insurance

Tuition reimbursement

PTO

Company events

Risks

Multiple class action lawsuits could lead to financial and reputational damage for Outset.

The shipment pause of TabloCart with Prefiltration may have disrupted supply chains.

Reliance on partnerships, like with U.S. Renal Care, poses risks if expectations aren't met.

Differentiation

Outset Medical's Tablo system integrates with EMR platforms for streamlined dialysis workflows.

The company offers a Vascular Access Program to enhance staff expertise in cannulation.

Outset Medical provides a Bridge Program for facilities transitioning to in-house dialysis services.

Upsides

Increased adoption of home dialysis solutions aligns with Outset's partnership with U.S. Renal Care.

The demand for portable dialysis machines supports the market potential for Outset's Tablo system.

Outset's FIPS 140-3 validation enhances cybersecurity, aligning with new medical device standards.

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