Regulatory Affairs Engineer (m/f/d)

ABX-CRO is a privately owned, internationally operating, clinical and pre-clinical contract research organisation. Since 2002 we provide a wide variety of services to customers in pharmaceutical, biotechnology, medical device and medical supply industries, ranging from pre-clinical proof of-concept studies to planning, conducting and analysis of clinical trials on innovative treatments for patients with unmet medical needs. Our long-term experience with molecular imaging and radiology for development of both diagnostics and therapeutics has created an important company focus, particularly in oncological and neurological disease areas. In addition to clinical research, we develop innovative software solutions for molecular radiotherapy applications. For further marketing of our dosimetry software suite, we are currently looking for a:

Regulatory Affairs Engineer (m/f/d)

YOUR TASKS AND RESPONSIBILITIES

  • Development of registration strategies for our medical device worldwide
  • Maintenance of existing registrations and execution of registrations in new countries
  • Surveillance of regulatory and legislative requirements
  • Assistance of development team in implementation of regulatory requirements
  • Assistance in technical documentation, CAPA and risk management
  • Consultation in product developments as contact person for regulatory questions
  • Participation and assistance of internal and external audits

YOUR QUALIFICATIONS

  • Completed study in medical engineering or sciences or similar qualifications
  • Experience in regulatory affairs for medical device
  • Knowledge in the medical device standards and regulations: Medical Device Regulation (EU) 2017/745, Medical Device Directive 93/42/EWG, DIN EN ISO 13485:2016
  • Ideally knowledge in 21 CFR Part 820, MDSAP
  • Reliable handling of documentation tools (MS Office)
  • Strong interest in optimization of quality processes
  • Analytical and conceptional skills as well as efficient organisation
  • Good comprehension and communication skills
  • Fluent in English, both written and spoken. German language skills are a plus.

WHAT WE OFFER

  • Collaboration in an interdisciplinary team
  • International contacts
  • Flexible working hours, flexible working place (home office)
  • A growing international team with more than average company loyalty
  • Internal training and qualification
  • Appropriate compensation reflecting your qualifications and job responsibilities

Please contact Sophia Wunder by e-mail (jobs@abx-cro.com) or by telephone (+49 351 21 444 258) for further information. If you are interested and you believe to be the right person to join our team, please send us your job application, including your CV, references and salary expectations via e-mail to jobs@abx-cro.com. Please compile your application letter and all supporting documents into a single PDF.

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