Head of Compliance & AMLCO leading compliance and AML/CTF function for Cyprus - regulated Electronic Money Institution. Serving as the primary point of contact with the Central Bank of Cyprus.
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
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
GRC Analyst supporting ISO27001 certification preparation at Asiera. Collaborating with technical teams for documentation and compliance.
Cyber GRC Senior Consultant supporting companies in enhancing cybersecurity and compliance. Collaborating with client teams to implement cybersecurity policies and conduct risk assessments.
Internal Controls & Compliance Supervisor managing compliance with SOX and internal controls at Solventum, a healthcare company enhancing solutions for healthcare professionals.
Regulatory Affairs Specialist ensuring compliance and strategic oversight at Multiverse. Drafting regulatory submissions and coordinating oversight processes within a hybrid work environment.
Director of Deposit Compliance responsible for leading compliance efforts for deposit products at Northwest Bank. Ensuring adherence to regulations and managing risk assessment processes for effective compliance operations.
Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.
Senior Specialist responsible for corrective actions in Global Trade Compliance at L3Harris. Track compliance incidents and facilitate corrective action processes across US and non - US jurisdictions.
Regulatory Affair Specialist at Capgemini Engineering ensuring regulatory compliance with medical device documentation. Supporting regulatory activities and monitoring the regulatory context impact on site processes.
Compliance Analyst role at Leve Saúde ensuring adherence to regulations in the health sector. Responsibilities include audits, policy management, and due diligence processes.