Senior Manager responsible for developing risk management systems and compliance processes at RBC. Collaborating with various teams to minimize investments risks in technology infrastructure.
TK
Hybrid Regulatory Affairs Manager – Medical Device
Posted 2 months ago
About the role
- Regulatory Affairs Manager ensuring compliance for medical devices in Tübingen, Germany. Overseeing technical documentation and regulatory strategies for medical device approval with hybrid work arrangement.
Responsibilities
- Prepare and update technical documentation for medical devices in accordance with MDR 2017/745
- Ensure compliance with applicable regulatory requirements
- Develop test plans, organize testing activities, and define test parameters and equipment
- Create standardized test reports to demonstrate compliance with relevant standards
- Serve as the primary contact for notified bodies during technical documentation reviews and for regulatory inquiries from development and production teams
- Define regulatory strategies for the approval of medical devices
Requirements
- Completed degree in engineering or natural sciences
- Professional experience in Regulatory Affairs for medical devices
- Knowledge of ISO 13485 and MDR
- Excellent German (C1) and English skills, both written and spoken
- Strong coordination and organizational skills
Benefits
- New career perspectives and comprehensive guidance for your Regulatory Affairs career
- Positions that match your skills, expertise, and goals
- Exclusive job opportunities with company background information
- Optimization of your application documents and thorough interview preparation
- Direct access to decision-makers and support in negotiating the best compensation package
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Compliance Regulatory Change officer ensuring timely identification and communication of regulatory changes affecting RBC businesses. Supporting compliance across Canadian financial sectors with impactful oversight.
Contracts & Compliance Manager at Giesecke and Devrient Mobile Security overseeing compliance and data privacy. Responsible for legal advice, contracts, and internal guidelines.
Regional Regulatory Manager ensuring environmental compliance for chemical distribution across Northeast US. Leading initiatives, audits, and reporting while providing strategic training and oversight.
Trade Compliance Officer supporting Export Control compliance activities within Defence Industry projects. Collaborating with managers to ensure adherence to regulations and operational support.
Senior Specialist in Compliance risk monitoring for pharmaceutical company. Involves data analysis and collaboration across global teams for risk management.
Associate Director leading Global Regulatory Affairs and Clinical Safety for pharmaceutical partnerships. Coordinating cross - functional activities to maintain regulatory obligations and compliance.
Oversee and optimize operations of the Business Administration Office at Princeton Hydro. Leading compliance and operational efficiency across multiple states as a seasoned professional.
Regulatory Data Assessment Analyst researching regulatory compliance for financial services at Truist Bank. Collaborating with stakeholders to validate data quality and enhance testing processes.
Senior Manager responsible for identifying and pursuing opportunities among US - based Japanese clients for Kroll. Involves business development, client relationship management, and forensic investigations.