Pre Market Quality and Regulatory Specialist (m/f/d)

Pre Market Quality and Regulatory Specialist (m/f/d)

Location: Bonn, North Rhine-Westphalia, Germany

Join Dedalus as a Pre-Market Quality and Regulatory Specialist. This role focuses on ensuring compliance and regulatory excellence for medical device products.

Responsibilities

• Ensuring process adherence for pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as part of cross-functional teams
• Creation and maintenance of key regulatory deliverables of the projects
• Regulatory and CE submissions in cooperation with regional QARA organizations
• Ensuring adherence to the medical device risk analysis process as risk moderator of the development team
• Facilitate regulatory compliance in design control processes to prevent compliance issues during inspections
• Perform internal audits and defend Dedalus pre-market activities during external regulatory inspections and audits
• Serve as a QARA ambassador on product teams

Qualifications

• University degree (Engineering, Computer Science or Science) or equivalent
• Minimum 3 years of experience in a regulated industry – preferably medical device, pharmaceutical or related – holding a position in project management, quality management, or quality assurance and regulatory affairs
• Ability to work independently toward project deadlines with strong attention to detail, and to analyse, understand, and interpret regulations and standards for a general business audience
• Subject matter expert in regulatory affairs with in-depth knowledge of health care quality standards and requirements (ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, MDR, IVDR)
• Awareness of Medical Device product safety and security standards (ISO 27001, GDPR, ANVISA, CMDCAS, FDA, SFDA)
• Expert PC operation skills, including Microsoft Office (Intermediate to Advanced)
• Mandatory language skills: at least B2 in German, English

What We Offer

• Permanent employment contract with attractive salary
• Flexible working hours and time models – good work‑life balance
• Home office with TicketPlusCity card from Edenred
• Flexitime model
• Innovative workplace with opportunities to shape your environment and develop skills
• Targeted advancement through training and specialist education
• Company cell phone (Android or iOS) also for private use
• Free parking spaces
• Free drinks and weekly fruit basket
• Company pension plan and working time accounts
• Group accident insurance (valid for accidents during free time)
• Foreign health insurance for business trips
• Regular activities and social events within the team and organization

EEO & Inclusion

We are an equal opportunity employer. Severely disabled applicants will be given special consideration if they are equally qualified.

Contact: Dedalus HealthCare GmbH, Human Resources, Monaiser Straße 11a, 54294 Trier, https://www.dedalusgroup.de