Product Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Take ownership of and oversee the product roadmap along with revenue goals for SureTrend's regulatory modules and traceability features.

• Prioritize functionalities based on compliance risks, customer value, technical feasibility, and alignment with strategic objectives.

• Convert global regulatory requirements and scheme mandates into product specifications, PRDs, user stories, and acceptance criteria.

• Establish the traceability data model and interoperability specifications, covering CTEs, KDEs, lot/batch genealogy, electronic recordkeeping, audit trails, and data exchange via API and SFTP with ERP/customer systems.

• Act as the internal expert on food safety workflows, including environmental monitoring, sampling plans, CCP monitoring and verification, corrective actions, and hold-and-release processes.

• Transform food safety workflows into product decisions and documentation for customers.

• Collaborate with Engineering in Azure DevOps on backlog refinement, sprint planning, and release coordination across regulatory and traceability projects.

• Keep track of the global regulatory landscape, post-launch adoption rates, defect occurrences, and audit results.

• Notify stakeholders of forthcoming mandates and foster cycles of continuous improvement.

• Provide senior-level product leadership across the portfolio.

• Guide and mentor product managers.

• Present regulatory strategies to executives and the Board.

• Equip Sales, Marketing, and Customer Success teams with clear compliance messaging.

⛳️ Requirements

• A Bachelor's Degree in Business Administration, Economics, Computer Science, or a related discipline is required; degrees in Engineering, Life Sciences, or Quality/Regulatory Affairs will also be taken into account.

• A minimum of 3–5 years of experience in product management, regulatory affairs, or quality assurance roles.

• At least 2 years of experience managing software products in regulated sectors such as life sciences, pharmaceuticals, medical devices, or manufacturing.

• Proven experience utilizing 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.

• Strong judgment concerning accuracy, data privacy, and compliance in a regulated setting.

• Comprehensive understanding of quality management systems and regulatory frameworks, including ISO 9001, ISO 13485, and ISO/IEC 17025.

• Familiarity with QMS processes such as document control, change control, deviation and nonconformance management, CAPA, training records, and management review.

• Experience with internal, supplier, and third-party audit programs as well as auditor/certification body objective evidence requirements.

• Knowledge of GxP and cGMP standards, including FDA 21 CFR Parts 210/211 and 820.

• Awareness of international regulatory standards across North America, the EU, and APAC.

• Familiarity with risk management, root cause analysis, and product traceability practices, including ISO 14971, FMEA, and lot/batch genealogy.

• Understanding of electronic records, electronic signatures, audit trails, and data integrity standards, including FDA 21 CFR Part 11, EU Annex 11, and ALCOA+.

• Comprehension of end-to-end quality workflows, including inspection and testing, laboratory results and COA flow, hold-and-release, recall preparedness, supplier qualification and verification, and complaint management.

• Experience in translating complex regulatory texts into software feature specifications, PRDs, and acceptance criteria.

• Familiarity with Agile/Scrum methodologies and Azure DevOps.

• Exceptional analytical skills for interpreting complex regulatory texts and deriving actionable product implications.

• Strong written communication abilities for regulatory summaries, PRDs, product briefs, and customer-facing compliance documentation.

• Excellent verbal communication and executive presentation skills.

• Capacity to engage with regulatory bodies, third-party auditors, compliance-focused customers, engineering teams, and executive stakeholders.

• Ability to manage multiple regulatory and traceability initiatives simultaneously in a fast-paced Agile environment.

• Strong judgment in balancing regulatory thoroughness with practical product compromises and business priorities.

• Proven track record of mentoring other product managers.

• Ability to navigate uncertainty and provide clarity across cross-functional teams.

• A proactive, self-motivated approach combined with a mindset focused on continuous improvement.

🏝️ Benefits

• 15 days of paid time off (PTO).

• 10 paid company holidays.

• Medical insurance with employer contributions to an HSA.

• Dental coverage.

• Vision coverage.

• Company-funded life insurance.

• Short-term disability coverage.

• Long-term disability coverage.

• Employee Assistance Program.

• 401(k) plan with Safe Harbor and profit-sharing employer contributions.

• Tuition reimbursement program.

• Charitable contribution matching.

• Opportunities for employee referral bonuses.

• A culture that promotes teamwork and cross-functional communication.

• Opportunities to support local organizations dedicated to enhancing the lives of children and youth.