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

Stellenbeschreibung:

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