Symmetrio

60 Symmetrio Jobs Hiring Near You

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 ...

Symmetrio is seeking for our client, a multi-national medical device company, a Clinical Applications Specialist with a dosimetry background. This position requires a thorough knowledge of treatment ...

Symmetrio is recruiting on behalf of a growing outpatient radiology organization seeking a skilled MRI Coil Repair Technician to join their technical operations team. This role is ideal for a hands ...

Sr. Service Technician (Robotics)

San Diego, CA ยท On-site

$135K - $160K/yr

Symmetrio is recruiting for our customer, an innovative and rapidly growing medical device company, for a Sr. Medical Technical Support Engineer based in San Diego, CA. This role is an excellent ...

Sr. Service Technician (Robotics)

San Diego, CA ยท On-site

$135K - $160K/yr

Symmetrio is recruiting for our customer, an innovative and rapidly growing medical device company, for a Sr. Medical Technical Support Engineer based in San Diego, CA. This role is an excellent ...

Senior Quality Assurance Specialist

Richland, WA ยท On-site

$86K - $118K/yr

Symmetrio is recruiting a Senior Quality Assurance Specialist for a growing medical device company in Richland, Washington. This position will provide quality oversight across the design ...

next page

Showing results 1-20

Symmetrio Jobs Information

Infographic showing various job openings at Symmetrio in the United States as of August 2026, with employment types broken down into 100% Full Time. Highlights an 62% Physical, and 38% Remote job distribution.

Regulatory Affairs Manager-US

Symmetrio

Remote

Full-time

Re-posted 14 days ago


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