Regulatory Affairs (IVD)

Location: Remote within the United States, with the posting specifying US-CA; occasional local travel and some out-of-area and overnight travel, less than 20%.

Salary: $104,774–$163,710 per year, plus eligibility for bonus, stock, and benefits.

Company

hirify.global develops and commercializes scientific, diagnostic, and laboratory technologies, including in-vitro diagnostic products.

What you will do

• Prepare, coordinate, and submit regulatory documentation and product registrations for the U.S., EU, Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating markets.
• Maintain technical files, GSPRs, CERs, regulatory registrations, licenses, SOPs, guidelines, templates, and training materials.
• Partner with R&D, Quality, and Commercial teams on product development, design controls, labeling, change control, and commercialization.
• Support risk assessments, complaints, non-conformances, CAPA, recalls, MDR, advisory notices, and other post-market compliance activities.
• Lead or support PMS and PMPF activities, including complaint trend analysis, vigilance reporting, literature research, and CER updates.
• Support audits and inspections, assess regulatory changes, perform gap analyses, and coordinate responses with internal teams, consultants, and local agents.

Requirements

• Bachelor’s degree or equivalent experience.
• At least three years of experience in medical devices, IVD, or a related regulated industry.
• Practical IVD regulatory experience and knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries.
• Knowledge of EU IVDR 2017/746, NMPA, MFDS, AMDD, ISO 13485, ISO 14971, MDSAP, cGMP, and GMP/QSR requirements.
• Strong analytical, communication, organizational, leadership, and project management skills.
• Experience with eQMS platforms such as MasterControl, Veeva Vault QMS, or AssurX.

Nice to have

• Experience with antibody-based diagnostics.
• Experience coordinating international regulatory consultants or local agents.

Culture & Benefits

• Remote work option for the full-time role.
• Day shift with no stated end date.
• Eligibility for bonus, stock, and benefits.
• Work across cross-functional regulatory, R&D, Quality, and Commercial teams.
• Opportunity to contribute to continuous improvement and company-wide regulatory training.