Product Manager

🔥 6 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $110k - $140k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

✅ Product Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Hygiena

WebsiteLinkedInAll Job Openings

501 - 1000 employees

🏨 Hospitality

📦 Logistics

🏭 Manufacturing

💰 Private Equity Round on 2016-07

Hospitality • Logistics • Manufacturing

Hygiena is a leading provider of innovative diagnostic solutions focused on hygiene and food safety testing. With an extensive range of products for the detection and monitoring of contaminants such as microorganisms, allergens, and mycotoxins, Hygiena serves various sectors including food and beverage, healthcare, hospitality, and pharmaceuticals. Their commitment to quality and safety ensures that businesses can meet the highest standards in their operations, promoting a healthier world through advanced technology and reliable testing solutions.

📋 Description

• 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