Senior Manager for IT SOX Compliance at Boeing overseeing the design and implementation of IT General Controls. Collaborating with IT leadership and working across various technology functionalities in a hybrid role.
About the role
- Regulatory Affairs Specialist at DentalMonitoring ensuring compliance for medical devices and managing regulatory strategies. Participating in quality compliance communications and documentation for market approval.
Responsibilities
- Participate in internal and external communications regarding quality and regulatory requirements
- Define regulatory strategies for health software and mobile health applications (SaMD)
- Prepare, submit and follow up on medical device registration dossiers
- Ensure collection, analysis and follow-up of post-market surveillance data
- Define, review and maintain regulatory product labeling
- Maintain continuous regulatory monitoring
Requirements
- Minimum of 4 years' experience in the Medical Devices sector
- Proven experience preparing and submitting technical documentation for CE marking (under MDR/IVDR) and/or for FDA submissions (510(k), De Novo, PMA)
- Engineering degree, Master’s in Regulatory Affairs, or a degree in a medical or scientific field
- Excellent organizational and analytical skills and strong attention to detail
- Full professional proficiency in English and French (minimum C1 level in both languages)
Benefits
- Swile lunch card
- Private health insurance (Alan)
- Free share allocation plan (equity grants)
- Hybrid work possible
- Active employee benefits program (CSE) — e.g., Urban Sports Club, club-employes.com
- Internal company events
- Employee referral bonus
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
No Education Requirement
Location requirements
Compliance Officer ensuring Defence sector regulations and certifications for a leading tech firm. Engaging in audits, compliance reviews, and serving as a liaison with authorities.
Health, Safety & Compliance Coordinator at CSN Collision ensuring health and safety across locations. Implementing programs and maintaining standards for compliance in the collision repair environment.
IT Compliance Expert leading GxP and CSV projects in the pharmaceutical sector. Responsible for strategic project planning and execution with innovative technologies.
Senior Manager in Regulatory Affairs overseeing biocides registration projects while providing regulatory advice at LANXESS. Collaborating with internal and external stakeholders to ensure compliance and business strategies.
Regulatory Consultant supporting clients in financial compliance and risk management. Collaborating with senior colleagues on advisory work and multi - jurisdictional consulting engagements.
Working Student assisting executives in a dynamic, international medical diagnostic services provider. Coordinating travel, meetings and events while supporting the management team across various projects.
Workforce Compliance Coordinator responsible for managing licensing and safety compliance for employees and contractors. Ensuring operational readiness and maintaining records across compliance portals.
Regulatory Coordinator supporting compliance in Docklands, Australia. Engaging with regulators and coordinating compliance activities between operations, legal, and authorities.
Compliance and Quality Control Manager at MVM, Inc. Ensuring compliance with policies, laws, and internal standards while managing quality control operations.