Compliance Officer conducting onsite and remote branch examinations at Aviso Wealth. Join our dynamic team improving the financial well - being of Canadians through compliance oversight.
About the role
- Senior Compliance Engineer ensuring compliance with regulatory standards for medical devices at Insulet. Collaborating with cross-functional teams to support design, development, and lifecycle maintenance.
Responsibilities
- Serve as a key member of cross‑functional project teams, including electrical, software, mechanical, manufacturing, and quality engineering, to support design, development, launch readiness, and lifecycle maintenance.
- Interface with nationally recognized test laboratories (NRTLs) to obtain and maintain product certifications.
- Collaborate with R&D staff to ensure consistent understanding and application of relevant standards and regulatory requirements across engineering disciplines.
- Develop compliance plans tailored to the scope, risk, and intended use of each program.
- Determine applicable U.S. and international standards in collaboration with Systems Engineering Leads, Regulatory Affairs, and Quality.
- Maintain working knowledge of FDA guidance and global standards related to mobile device technologies in medical products.
- Interpret external standards and ensure ongoing compliance via reviews of product changes.
- Monitor changes to regulatory requirements and external standards, performing gap analyses and communicating impacts to internal stakeholders.
- Coordinate and support system-level testing against relevant external safety, software, EMC, usability, and wireless standards.
- Organize and manage third‑party lab testing, documentation, reports, and compliance activities.
- Ensure that components critical to product safety are certified and properly documented.
- Audit Support & Compliance Governance
- Support internal audit readiness activities and respond to certification body inquiries.
- Coordinate cross‑functional compliance activities, ensuring alignment with program timelines, deliverables, and quality system requirements.
- Provide guidance to senior and executive leadership on critical compliance matters impacting product development, certification, or market access.
Requirements
- Bachelor’s degree required (preferred field of study: Systems Engineering, Electrical Engineering, Mechanical Engineering, Computer Science, Biomedical Engineering, or related technical field); Master’s degree preferred.
- Minimum five (5) years of experience as a Systems or Compliance Engineer in a multidisciplinary medical device environment.
- Five (5)+ years leading compliance‑specific initiatives for regulated medical devices in U.S. and international markets.
- Proficiency with key medical device standards and regulations, including ISO 13485, ISO 14971, IEC 62304, IEC 60601, IEC 62366, 21 CFR 820.30, and EU MDR; knowledge of additional in‑country standards is a plus.
- Domain expertise in one or more engineering disciplines, preferably Electrical Engineering, with exposure to Mechanical, Quality, and Test Engineering.
- Demonstrated systems engineering skills including requirements management, design trade‑offs, hazard analysis, safety assessments, and risk management.
- Deep understanding of medical device and software compliance standards, and the ability to apply appropriate test strategies based on device design.
- Proven ability to work effectively under a Quality Management System (QMS) within cross‑functional teams across development, V&V, manufacturing, regulatory, marketing, clinical, and quality functions.
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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