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SymmetrioSY

Regulatory Affairs Manager-US

Symmetrio is a full-service recruiting, staffing, and consulting company with decades of experience across a range of high-growth industries, delivering targeted talent solutions.

Symmetrio

Employee count: 51-200

United States only

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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

About the job

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Posted on

Job type

Full Time

Experience level

Location requirements

Hiring timezones

United States +/- 0 hours

About Symmetrio

Learn more about Symmetrio and their company culture.

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At Symmetrio, our core mission revolves around a profound understanding of our clients' unique business needs, organizational structures, cultural nuances, and operational hurdles. We firmly believe that the right talent is the cornerstone of any successful organization. This conviction drives our personalized staffing and recruiting services, meticulously tailored to meet specific business and functional requirements. Our approach is distinguished by the organization of our team into specialized Practice Areas. This structure allows us to concentrate our skills and experience effectively, with Practice Leaders who are seasoned industry veterans. These leaders bring a wealth of operational expertise from their respective market sectors, enabling them to address the distinct demands of your business with precision and insight.

Since our inception in 2012, Symmetrio has been dedicated to helping companies discover and secure top-tier talent. We recognize that the economic landscape is in a constant state of flux. Therefore, we offer a comprehensive suite of services that includes not only permanent placements but also flexible recruiting and staffing solutions. This adaptability ensures that we can meet the evolving hiring needs of your organization, empowering you to navigate economic fluctuations with confidence and agility. Our commitment extends beyond simply filling positions; we strive to become trusted advisors. By working in close collaboration with you, we provide strategic insights and guidance on organizational design. This ensures that the talent we deliver not only aligns with your position objectives but also integrates seamlessly into your organizational culture, fostering long-term success and growth. Your success is, and always will be, our primary mission.

Employee benefits

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401k Retirement Plan

Symmetrio provides a 401k retirement plan.

401(k) match

Symmetrio offers a 401(k) matching program.

Flexible Scheduling

Symmetrio offers flexible scheduling options.

Car allowance

Symmetrio provides a car allowance for certain roles.

View Symmetrio's employee benefits
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Symmetrio

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