Manager Regulatory Affairs

Outset Medical Inc. - San Jose, CA (30+ days ago)


Company Description

Outset Medical is a privately held company backed by a top-tier syndicate of investors, including Fidelity, T. Rowe Price and Warburg Pincus, pioneering the use of a new dialysis medical technology ecosystem that could profoundly change the way hemodialysis treatment is delivered. Historically, patients have had to endure little choice and control over their treatments in dialysis clinics, creating one of the least consumer-friendly sectors in medicine, and making it one of the most labor-intensive and costly for the providers who sustain it. Outset is introducing a new technology aimed at disrupting both the cost structure and patient experience of dialysis within four market segments -- dialysis clinics, hospitals, extended care facilities and home.

Position Overview

Responsible for managing Regulatory Affairs activity supporting both pre-market and post-market projects on an on-going basis in line with the Quality Management System and Quality Policy to ensure that the business’ products and services are fit for purpose and meet customer expectations. Responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advise on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues. The incumbent for this position will support additional activities as assigned.

Essential Job Functions

  • Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
  • Complete submissions to FDA, EU regulatory entities.
  • Create and maintain product EU technical files.
  • Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
  • Supervise Regulatory Affairs consultants as required.
  • Support External Audits.
  • Lead and manage CAPA related projects, as needed.
  • Facilitate Post-Market Surveillance reports.
  • Develop and maintain strong relationships with internal and external stakeholders to ensure optimal performance
  • Excellent interpersonal skills
  • A self-starter, motivated and able to positively motivate others
  • Focused, target driven with a positive, can-do attitude

People Management:

  • Provide leadership, direction, management and development to project teams
  • Set department objectives/KPIs and review and assess ongoing performance of direct reports
  • Report on achievement of targets and identify any actions required
  • Motivate and coach the team to operational success

Requirements/Qualifications

  • Bachelor’s degree in Engineering or Science (or similar).
  • RAC certification or equivalent.
  • Minimum of 10+ years of hands on experience with increasing Regulatory Affairs responsibilities.
  • Experience with External Audits (FDA and Notified Body) presenting topics/data related to Regulatory Affairs.
  • Prior experiences in the medical device space, preferably in working on Capital Equipment devices.
  • Ability to work effectively in a fast paced and dynamic environment.
  • Leadership and interpersonal skills to develop and manage good working relationships with internal departments (manufacturing, receiving, purchasing, product development, and regulatory), contractors, and suppliers; strong written and verbal communication skills.

Job Type: Full-time

Experience:

  • Regulatory Affairs: 4 years

Location:

  • San Jose, CA

Minimum Previous Legal Responsibility required:

  • Manager / Lead