Sr. Regulatory Affairs Specialist - Recall and Post-Market Compliance (Hybrid/Remote)

Location: Remote or hybrid in the United States, including Southern California and other listed US locations

Base salary: $90,000–$135,000 per year, plus eligible variable cash compensation and equity

Company

hirify.global develops genomic technology that supports early disease detection, diagnosis, and new treatment options.

What you will do

• Support post-market regulatory compliance for on-market in vitro diagnostic products in US and international markets.
• Assess adverse events and field actions for regulatory reportability and support MDR and recall decisions.
• Coordinate regulatory reporting, prepare justifications and submission documentation, and manage submission deliverables.
• Develop regulatory strategies and plans for new products and existing marketing authorizations.
• Review labeling, manufacturing changes, validation, clinical, and stability documentation for regulatory compliance.
• Create procedures, work instructions, templates, and training that improve post-market oversight.

Requirements

• Minimum 5 years of related experience with a bachelor's degree, 3 years with a master's degree, or a PhD without experience, or equivalent work experience.
• 5+ years of experience in Regulatory Affairs.
• Strong understanding of FDA regulations.
• Experience with in vitro diagnostic, pharmaceutical, biologics, or medical device companies.
• Ability to work independently with complex technologies and produce professional regulatory documentation.
• Strong written and verbal communication skills and the ability to deliver work on time.

Nice to have

• Knowledge of regulatory requirements in the EU, Canada, Australia, Japan, and China.
• Team leadership skills.
• Experience with office automation programs and corporate database tools.

Culture & Benefits

• Inclusive, collaborative environment focused on innovation in genomics.
• Health, dental, and vision coverage.
• Retirement benefits and paid time off.
• Family planning support and access to genomics sequencing.
• Employee Resource Groups and career development opportunities.
• This role is not eligible for visa sponsorship.