Symmetrio

Regulatory Manager-US

Symmetrio  •  United States (Remote)  •  23 days ago
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Job Description

Symmetrio is recruiting for our client for a Regulatory Affairs Manager to lead U.S. regulatory strategy and submissions for innovative healthcare software products. This role will focus on FDA 510(k) submissions and regulatory pathways for Software as a Medical Device (SaMD) within a global, multinational environment.

Key Responsibilities

  • Lead preparation and submission of FDA 510(k) filings for healthcare software and digital health products
  • Develop and execute regulatory strategies supporting product development and commercialization
  • Collaborate with product development, quality, clinical, and engineering teams to ensure regulatory compliance
  • Interpret FDA guidance related to medical device software and digital health technologies
  • Partner with global regulatory teams to support international regulatory initiatives

Requirements

  • 5–10+ years of regulatory affairs experience in medical devices or healthcare software
  • Proven experience with FDA 510(k) submissions, ideally for software-based medical devices
  • Strong knowledge of SaMD, FDA regulations, and quality standards (21 CFR Part 820, ISO 13485, IEC 62304)
  • Experience working within a multinational organization
  • Strong cross-functional collaboration and communication skills
Symmetrio

About Symmetrio

Symmetrio prides itself on our unwavering dedication to understanding clients’ unique needs, organizational design, culture, and operational challenges. We recognize the ever-changing economic landscape and offer not only permanent placement services but also flexible recruiting and staffing solutions. Our flexible service offerings ensure that we adapt to the hiring needs of your organization, allowing you to navigate through economic fluctuations.

Our primary mission is to listen, gain your respect and trust to become a trusted advisor providing strategic insights and collaborate on organizational design considerations based on our Practice Leaders deep operational experience in your industry. This collaboration allows us to ensure the talent we deliver not only aligns with your position objectives but also perfectly fits your organizational culture. Partnering with Symmetrio affords you more than just a recruitment service; you gain a team that is committed to your long-term success leveraging our unique knowledge and experience of what it takes to thrive in your industry.

At Symmetrio, we understand the importance of having the right talent in every area of your organization. That’s why we offer personalized staffing and recruiting services tailored to meet your specific business and functional needs. We take pride in our unique approach of organizing our team by Practice Area, allowing us to better focus our skills and experience. Our Practice Leaders, who are industry veterans in their respective market sectors, bring a wealth of expertise as business operators to tackle the distinctive demands of your business.

Industry
HR & Recruiting
Company Size
11-50 employees
Headquarters
Erdenheim, PA
Year Founded
2012
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