Compliance

• Core member of medical device and combination product development teams, providing high quality regulatory input to ensure that the developed product meets global Health Authority expectations
• Primary point of contact for Notified Body and global Health Authorities for stand-alone medical device registrations and leadership of MDR Article 117 Notified Body Opinion interactions
• Deliver high quality regulatory documents to support global Health Authority submissions for combination products and stand-alone medical devices
• Supports audit readiness activities and inspections for medical devices and combination products including obtainment and maintenance of certification for stand-alone medical devices
• Write and maintain high-quality regulatory documents and responses for Health Authorities and Notified Bodies according to established guidelines, processes, IT systems and SOPs, to ensure technical congruency and regulatory compliance while meeting agreed timelines and submission requirements
• Regulatory lead for the development / manufacture of medical devices and combination products, including management of relevant registration, certification, and audit requirements
• Operational owner of medical device and combination product related deliverables and timelines
• Regulatory device lead for post approval phase, supporting global registrations, responsible for evaluation of changes, definition of implementation strategies and submission of variations
• Strategic oversight of medical device and combination product regulatory activities – ability to lead others to ensure successful identification of device deliverables, completion of deliverables in-line with development milestones and successful integration into dossiers and successful response to health authority deficiency letters or requests for information

RA Manager – Regulatory Devices

• Take on responsibility for export control and customs topics in an international environment.
• Perform export control reviews of business transactions and ensure compliance with relevant national, European and international regulations.
• Manage export control licenses and contribute to the further development of internal guidelines, work instructions, and processes in the areas of export control and customs.
• Prepare analyses, reports and documentation for internal audits, management, and external authorities.
• Participate in cross-functional projects to optimize and further develop export control and customs processes.
• Support the customs team in preparing import- and export-related documents and statistics, as well as maintaining customs- and foreign trade-related master data and records.
• Ensure proper, complete, and audit-ready documentation of all export control- and customs-related activities.

Trade Compliance Specialist – Officer

• Organize and coordinate board meetings, assemblies, and international high-level meetings (online and in-person)
• Prepare meeting minutes, document key decisions, and monitor follow-up actions to ensure timely implementation
• Ensure timely statutory filings and monitor compliance with internal and external governance deadlines
• Coordinate board member onboarding and offboarding processes
• Maintain governance-related communication channels and documentation
• Act as the primary administrative contact for board members
• Support management of governance budgets and expenses
• Contribute to innovation and continuous improvement initiatives in governance processes

Compliance jobs in Austria

See all jobs on JobTailor

RA Manager – Regulatory Devices

Trade Compliance Specialist – Officer

Compliance & Governance Assistant