Product Manager

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

📋 Description

• Take ownership of the product roadmap and revenue goals for SureTrend's regulatory modules and traceability functionalities.

• Prioritize features based on compliance risks, customer value, technical feasibility, and strategic alignment.

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

• Establish traceability data models and interoperability requirements, including CTEs, KDEs, lot/batch genealogy, electronic recordkeeping, audit trails, and data exchange with ERP/customer systems via API and SFTP.

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

• Transform food safety workflows into product decisions and customer-facing documentation.

• Collaborate with Engineering in Azure DevOps for backlog refinement, sprint planning, and release coordination.

• Track the global regulatory environment, post-launch adoption, defect rates, and audit results.

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

• Provide senior-level product leadership across the entire portfolio.

• Mentor product managers.

• Represent the regulatory strategy to executives and the Board.

• Support Sales, Marketing, and Customer Success 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 considered.

• A minimum of 3 to 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 using AI tools, including large language models and AI-assisted prototyping and design tools.

• Strong judgment regarding data accuracy, privacy, and compliance in regulated settings.

• Extensive knowledge of quality management systems and regulatory standards, including ISO 9001, ISO 13485, ISO/IEC 17025, FDA 21 CFR Parts 210/211 and 820, FDA 21 CFR Part 11, EU Annex 11, and ALCOA+.

• 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 and the requirements for audit evidence.

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

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

• Comprehension 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.

• Demonstrated ability to translate intricate regulatory text into software feature specifications, PRDs, and acceptance criteria.

• Familiarity with Agile/Scrum methodologies and Azure DevOps.

• Exceptional analytical abilities for interpreting complex regulatory text and deriving actionable product implications.

• Strong writing skills for creating regulatory summaries, PRDs, product briefs, and compliance documentation for customers.

• Excellent verbal communication skills and executive presence.

• Capable of engaging with regulatory bodies, third-party auditors, compliance-focused clients, engineering teams, and executive stakeholders.

• Proficient in leading multiple regulatory and traceability workstreams concurrently in a dynamic Agile environment.

• Strong judgment in balancing regulatory thoroughness with practical product trade-offs and business priorities.

• Collaborative leadership style, customer-first mentality, strong sense of ownership, and mentoring experience.

• Ability to navigate ambiguity and bring clarity to cross-functional teams.

• Self-motivated individual with a mindset focused on continuous improvement.

🏝️ Benefits

• 15 days of Paid Time Off (PTO).

• 10 paid holidays each year.

• Medical insurance with employer contributions to an HSA.

• Dental insurance coverage.

• Vision insurance.

• Company-funded life insurance.

• Short-term and long-term disability coverage.

• Employee Assistance Program.

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

• Tuition reimbursement program.

• Matching contributions for charitable donations.

• Opportunities for employee referral bonuses.

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

• Support for community giving and local organizations.