Description

You will ensure operational excellence by managing quality audits and regulatory filings. Your day-to-day involves refining quality systems and mentoring teams to maintain global compliance standards.

Requirements

• •Master's degree in scientific discipline or comparable
• •Supervisory experience in regulated environment
• •Medical device and ISO certification qualifications
• •Effective collaboration in cross-functional teams
• •Experience with notified bodies and auditing
• •Qualification as medical device manufacturing auditor
• •Knowledge in regulations and authority interfacing
• •Expertise in major regulatory submissions
• •Strong interpersonal and personnel dealing skills
• •Advanced organizational and prioritization skills
• •Business fluent German and English skills
• •Willingness to travel approximately 20%

Tasks

• •Manage the business unit quality audit program
• •Provide specialist input for regulatory affairs processes
• •File applications and manage interactions with authorities
• •Write and review governing quality system procedures
• •Support continuous process improvement efforts
• •Maintain risk assessments for compliance-related elements
• •Monitor staff training records and personnel files
• •Track deviations and master schedules
• •Review protocols and reports for internal and external projects
• •Coordinate responses to observations and incidents
• •Update databases to ensure accuracy and compliance
• •Prepare and edit documentation for regulatory submissions
• •Develop operating guidelines and shared work practices
• •Create optimal strategies for assigned projects
• •Implement regulatory strategies for upcoming regulations
• •Offer guidance to multidisciplinary teams on compliance
• •Train and mentor team members and consultants

Tools & Technologies

Benefits