Product Manager

Hygiena LLC is seeking a full-time, remote, exempt Product Manager to own SureTrend’s regulatory modules and traceability product roadmap and requirements. In this role, you will convert global food safety and regulatory mandates into clear product decisions, partnering with Engineering to deliver software in Agile environments.

Role Responsibilities

• Own and maintain the product roadmap and revenue objectives for SureTrend’s regulatory modules and traceability capabilities, prioritizing features based on compliance risk, customer value, technical feasibility, and strategic alignment.
• Translate global regulatory mandates and scheme requirements, including FSMA and FSMA Section 204 (Food Traceability Rule), HACCP/Codex Alimentarius, GFSI-benchmarked standards (SQF, BRCGS, FSSC 22000), and EU General Food Law, into prioritized product requirements, PRDs, user stories, and acceptance criteria.
• Define the traceability data model and interoperability requirements, including Critical Tracking Events (CTEs) and Key Data Elements (KDEs), lot/batch genealogy, electronic recordkeeping, audit trails, and data exchange with ERP and customer systems via API and SFTP.
• Act as an internal subject matter expert for food safety workflows such as environmental monitoring programs, sampling plans, CCP monitoring and verification, corrective actions, and hold-and-release, translating them into product decisions and customer-facing documentation.
• Partner with Engineering in Azure DevOps for backlog refinement, sprint planning, and release coordination across regulatory and traceability workstreams.
• Monitor the global regulatory landscape and post-launch adoption, defect rates, and audit outcomes; proactively alert stakeholders to upcoming mandates and drive continuous improvement cycles.
• Provide senior-level product leadership across the portfolio, including mentoring product managers, representing regulatory strategy to executives and the Board, and supporting Sales, Marketing, and Customer Success with clear compliance positioning.

Required Qualifications

• Bachelor’s Degree in Business Administration, Economics, Computer Science or a related field required; Engineering, Life Sciences, or Quality/Regulatory Affairs degrees will also be considered.
• Minimum 3-5 years of experience in product management, regulatory affairs, or quality assurance roles, including at least 2 years managing software products for regulated industries such as life sciences, pharmaceuticals, medical devices, or manufacturing.
• Demonstrated experience leveraging AI tools (for example, large language models and AI-assisted prototyping and design tools) to accelerate product work, including market and regulatory research, rapid prototyping, UX design, requirements definition, and documentation, with sound judgment on accuracy, data privacy, and compliance in a regulated environment.
• Strong working knowledge of quality management systems and related regulatory frameworks, including:
  • Quality management system standards such as ISO 9001, ISO 13485, and ISO/IEC 17025, and how they are applied and audited in regulated organizations.
  • Core QMS processes including document control, change control, deviation and nonconformance management, CAPA, training records, and management review.
  • Internal, supplier, and third-party audit programs, and the objective evidence auditors and certification bodies expect.
  • GxP and cGMP requirements (including FDA 21 CFR Parts 210/211 and 820) and awareness of international regulatory expectations across North America, the EU, and APAC.
  • Risk management, root cause investigation, and product traceability practices (including ISO 14971, FMEA, lot/batch genealogy).
  • Electronic records, electronic signature, audit trail, and data integrity requirements (including FDA 21 CFR Part 11, EU Annex 11, ALCOA+).
• Working understanding of end-to-end quality workflows, including inspection and testing, laboratory result and COA flow, hold-and-release, recall readiness, supplier qualification and verification, and complaint handling.
• Demonstrated experience converting dense regulatory text into software feature specifications, PRDs, and acceptance criteria.
• Familiarity with Agile/Scrum practices and tools such as Azure DevOps.
• Exceptional analytical skills, including the ability to parse dense regulatory text and extract actionable product implications.
• Strong written communication skills, including producing clear regulatory summaries, PRDs, product briefs, and customer-facing compliance documentation.
• Excellent verbal communication and executive presence, including comfort engaging regulatory bodies, third-party auditors, and compliance-focused customers, and presenting to engineering teams and non-technical executive stakeholders.
• Proven ability to lead multiple regulatory and traceability workstreams simultaneously with competing timelines in a fast-paced Agile environment.
• Strong judgment to balance regulatory completeness with practical product tradeoffs and commercial priorities.
• Collaborative leadership with a customer-first mindset, strong ownership, and experience mentoring other product managers.
• Comfort navigating ambiguity and driving clarity across cross-functional teams.
• Proactive self-starter with a continuous improvement mindset.

Preferred/Additional Qualifications

• MBA or other advanced degree.

Technologies

• Azure DevOps
• API
• SFTP
• Agile/Scrum
• Large language models
• AI-assisted prototyping and design tools

Location and Employment Details

Location: Camarillo, CA (remote)
Employment: Full-time, remote, exempt
Salary: USD 110,000 - 140,000 per year
Minimum experience: 3 years

Benefits

• 15 days of PTO and 10 paid company holidays
• Medical with HSA employer contribution, Dental, Vision available 1st of the month after start date
• Company paid Life Insurance, Short and Long-Term Disability, and an Employee Assistance Program
• 401(k) with Safe Harbor and Profit-Sharing employer contributions
• Tuition Reimbursement program
• Charitable Contribution matching
• Employee Referral bonus opportunities
• State paid short-term disability for California based employees

Company Values and Culture

• Teamwork as a core value
• Be a part of something big
• Giving back to communities

Equal Opportunity

• All employment decisions are based on qualifications, merit, and business need.
• Qualified applicants receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.