Product Manager

Hygiena provides rapid microbiology diagnostic tests and solutions, with a core focus on food safety. The company is seeking a Product Manager to own the roadmap and revenue objectives for SureTrend’s regulatory modules and traceability capabilities, translate regulatory requirements into product specifications, and lead cross-functional regulatory and traceability workstreams.

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 - FSMA and FSMA Section 204 (Food Traceability Rule), HACCP/Codex Alimentarius, GFSI-benchmarked standards (SQF, BRCGS, FSSC 22000), and EU General Food Law - into clear, 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
• Serve as the internal subject matter expert for food safety workflows - 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 - mentoring product managers, representing regulatory strategy to executives and the Board, and enabling Sales, Marketing, and Customer Success with clear compliance positioning

Requirements:

• Bachelor's Degree in Business Administration, Economics, Computer Science or a related field required; degrees in Engineering, Life Sciences, or Quality/Regulatory Affairs will also be considered
• Minimum of 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 (e.g., large language models, 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 (e.g., 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 (e.g., ISO 14971, FMEA, lot/batch genealogy)
• Electronic records, electronic signature, audit trail, and data integrity requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, ALCOA+)
• Working understanding of end-to-end quality workflows - 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 with the ability to parse dense regulatory text and extract actionable product implications
• Strong written communication skills; able to produce clear regulatory summaries, PRDs, product briefs, and customer-facing compliance documentation for diverse audiences
• Excellent verbal communication and executive presence; comfortable engaging regulatory bodies, third-party auditors, and compliance-focused customers, and presenting to both 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 and ability to balance regulatory completeness with practical product tradeoffs and commercial priorities
• Collaborative leader with a customer-first mindset, strong ownership mentality, and a track record of mentoring other product managers
• Comfortable navigating ambiguity and driving clarity across cross-functional teams
• Proactive self-starter with a continuous improvement mindset
• MBA or other advanced degree a plus