Senior Compliance Analyst

Job Description

Job Summary

The Senior Product Compliance Analyst ensures products comply with applicable regulatory, safety, environmental, and quality standards across multiple markets (U.S., Canada, and international). This includes preparing submissions, performing assessments, advising on design changes, supporting post-market surveillance, and guiding cross-functional teams on regulatory matters.

Key Responsibilities

• Lead or support regulatory assessments for new and modified products to determine applicability of standards, directives, and regulations (e.g., for U.S., Canada, and emerging markets).
• Prepare and manage regulatory submissions, applications, declarations, and registrations with agencies (e.g. FDA, Health Canada, other national authorities).
• Monitor regulatory changes globally and assess impact on existing products and roadmaps.
• Provide guidance to engineering, product development, quality, and manufacturing teams to ensure compliance from early design stages through commercialization.
• Review and approve labeling, instructions for use (IFU), packaging, and promotional / marketing materials to ensure regulatory consistency.
• Perform or coordinate compliance testing, audits, and inspections (internal and external).
• Support post-market activities : adverse event reporting, recalls, corrective & preventive actions (CAPA), regulatory audits.

Qualifications

Education & Experience

Bachelor’s degree in a scientific discipline (e.g. Biology, Engineering, Chemistry) or related field (or equivalent experience).

Skills / Competencies

Preferred / Nice-To-Have