Product Manager

Hygiena LLC

• $110K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in Business Administration, Economics, Computer Science, or related field; advanced degrees preferred.
  • 3-5 years in product management, regulatory affairs, or quality assurance, with 2 years in software for regulated industries.
  • Experience using AI tools for product development and regulatory research, ensuring compliance and data privacy.
  • Strong knowledge of quality management systems and regulatory frameworks, including ISO standards and GxP requirements.
  • Ability to translate complex regulatory texts into clear product specifications and acceptance criteria.
  • Familiarity with Agile/Scrum methodologies and tools like Azure DevOps.

Responsibilities

  • Own and manage the product roadmap for regulatory modules and traceability capabilities, prioritizing features based on compliance and customer value.
  • Translate global regulatory mandates into clear product requirements and user stories.
  • Define traceability data models and interoperability requirements, ensuring compliance with industry standards.
  • Act as the subject matter expert for food safety workflows, guiding product decisions and documentation.
  • Collaborate with Engineering for backlog refinement and sprint planning in Azure DevOps.
  • Monitor regulatory landscape and product performance, driving continuous improvement initiatives.
  • Provide senior-level product leadership, mentoring other product managers and representing regulatory strategy to executives.

Benefits

  • 15 days of PTO & 10 paid company holidays
  • Medical with HSA employer contribution, Dental, Vision available after start date
  • Company paid Life Insurance, Short and Long-Term Disability, and Employee Assistance Program
  • 401(k) with Safe Harbor and Profit-Sharing contributions
  • Tuition Reimbursement program
  • Charitable Contribution matching
  • Employee Referral bonus opportunities
Full Job Description
With rapid growth comes opportunity. We are looking for a Product Manager to join our team! This is a full-time, remote, exempt position.

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.


Qualifications:

  • 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. MBA or other advanced degree a plus.
  • 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.


Skills:

  • 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.


Benefits and Perks:
  • 15 days of PTO & 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

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