Outset Medical, Inc.
Better begins now.
dialysis • medical devices • capital equipment • healthcare • patient care
501 - 1000
Manager, Regulatory Affairs
August 31
🏢 In-office - Bay Area
Outset Medical, Inc.
Better begins now.
dialysis • medical devices • capital equipment • healthcare • patient care
501 - 1000
Description
• Plan, track, and manage complex regulatory projects. • Craft regulatory strategies and comprehensive regulatory submissions. • Collaborate with cross-functional teams and regulatory agencies. • Lead teams in executing regulatory programs and project plans. • Review and approve promotional material. • Maintain SOPs related to regulatory affairs. • Conduct internal audits for compliance. • Identify potential risks and develop mitigation strategies. • Provide strategic regulatory guidance on commercial activities. • Support additional activities as assigned.
Requirements
• Bachelor's degree in Life Sciences, Engineering or equivalent. • Minimum 10 years’ experience in Regulatory Affairs within the Medical Device industry • Direct experience in authoring regulatory submissions end-to-end. • Proven track record in leading successful US FDA submissions. • Prior experience in reviewing and approving ad/promo material. • In-depth knowledge of relevant regulations and standards. • Proven experience in regulatory affairs, with a focus on project management. • Strong project management skills. • Good communication and interpersonal skills. • Detail-oriented with a high level of accuracy. • Ability to work collaboratively in a cross-functional team environment. • Can operate independently and have excellent problem-solving skills.
Benefits
• Privacy is important • Equal opportunity employer committed to diversity
Apply Now
