Product Manager
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Job Description
Product Manager advancing Hygiena’s food-safety diagnostic software and regulatory traceability products. Translating global regulations into product roadmaps, requirements, and compliant customer solutions.
Responsibilities:
- Own and maintain the product roadmap and revenue objectives for SureTrend's regulatory modules and traceability capabilities
- Prioritize features based on compliance risk, customer value, technical feasibility, and strategic alignment
- Translate global regulatory mandates and scheme requirements into product requirements, PRDs, user stories, and acceptance criteria
- Define the traceability data model and interoperability requirements, including CTEs, KDEs, lot/batch genealogy, electronic recordkeeping, audit trails, and ERP/customer-system data exchange via API and SFTP
- Serve as the internal subject matter expert for food safety workflows, including environmental monitoring, sampling plans, CCP monitoring and verification, corrective actions, and hold-and-release
- Translate food safety workflows into product decisions and customer-facing documentation
- Partner with Engineering in Azure DevOps on backlog refinement, sprint planning, and release coordination across regulatory and traceability workstreams
- Monitor the global regulatory landscape, post-launch adoption, defect rates, and audit outcomes
- Alert stakeholders to upcoming mandates and drive continuous improvement cycles
- Provide senior-level product leadership across the portfolio
- Mentor product managers
- Represent regulatory strategy to executives and the Board
- Enable 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
- At least 2 years managing software products for regulated industries such as life sciences, pharmaceuticals, medical devices, or manufacturing
- Demonstrated experience leveraging AI tools, including large language models and AI-assisted prototyping and design tools, for market and regulatory research, rapid prototyping, UX design, requirements definition, and documentation
- Sound judgment regarding accuracy, data privacy, and compliance in a regulated environment
- Strong working knowledge of quality management systems and regulatory frameworks, including ISO 9001, ISO 13485, and ISO/IEC 17025
- Knowledge of QMS processes including document control, change control, deviation and nonconformance management, CAPA, training records, and management review
- Experience with internal, supplier, and third-party audit programs and auditor/certification-body objective evidence requirements
- Knowledge of GxP and cGMP requirements, including FDA 21 CFR Parts 210/211 and 820
- Awareness of international regulatory expectations across North America, the EU, and APAC
- Knowledge of risk management, root cause investigation, and product traceability practices, including ISO 14971, FMEA, and lot/batch genealogy
- Knowledge of electronic records, electronic signatures, audit trails, and data integrity requirements, including FDA 21 CFR Part 11, EU Annex 11, and ALCOA+
- Understanding of end-to-end quality workflows, including inspection and testing, laboratory results and COA flow, hold-and-release, recall readiness, supplier qualification and verification, and complaint handling
- Experience converting dense regulatory text into software feature specifications, PRDs, and acceptance criteria
- Familiarity with Agile/Scrum practices and Azure DevOps
- Exceptional analytical skills for parsing dense regulatory text and extracting actionable product implications
- Strong written communication skills for regulatory summaries, PRDs, product briefs, and customer-facing compliance documentation
- Excellent verbal communication and executive presentation skills
- Ability to engage regulatory bodies, third-party auditors, compliance-focused customers, engineering teams, and executive stakeholders
- Ability to lead multiple regulatory and traceability workstreams simultaneously in a fast-paced Agile environment
- Strong judgment balancing regulatory completeness with practical product tradeoffs and commercial priorities
- Track record of mentoring other product managers
- Ability to navigate ambiguity and drive clarity across cross-functional teams
- Proactive, self-starting approach with a continuous improvement mindset
Benefits:
- 15 days of PTO
- 10 paid company holidays
- Medical with HSA employer contribution
- Dental insurance
- Vision insurance
- Company-paid life insurance
- Short-term disability
- Long-term disability
- Employee Assistance Program
- 401(k) with Safe Harbor and profit-sharing employer contributions
- Tuition reimbursement program
- Charitable contribution matching
- Employee referral bonus opportunities
- Teamwork and cross-functional communication culture
- Opportunities to support local organizations committed to improving the lives of children and youth
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