Design and Compliance Specialist

4 days ago


Ballerup, Ballerup Kommune, Denmark GN Store Nord AS Full time
About the Role

We are seeking an experienced Design and Compliance Specialist to join our R&D Hearing team in Poland. As a key member of this global team, you will contribute to the development of software for Hearing Instruments.

Job Summary

The successful candidate will be responsible for planning and implementing Design Control deliverables for Medical Device SW projects in compliance with corporate Quality Management Systems and regulated standards. This includes facilitating design reviews, participating in risk assessments, and overseeing audit processes.

Key Responsibilities
  • Plan and coordinate completion of Software Development deliverables in compliance with corporate QMS and IEC 62304
  • Facilitate design reviews, participate in risk assessments etc. to ensure compliance
  • Work with Corporate Quality and internal stakeholders to streamline, optimize and improve compliance documentation
  • Oversee audit processes, including findings from GN Online Services and Fitting Software
  • Improve and optimize Design Control process
Requirements

To succeed in this role, we imagine that you have:

  • 5+ years in Medical Device Industry
  • Proficiency in English
  • Solid understanding of Medical Device Design Control and regulations (21 CFR 820.30, ISO 13485, ISO 14971, IEC 62304, IEC 62366, 21 CFR 820.30)
  • Demonstrated initiative; results oriented; willingness and ability to institute change
  • Ability to communicate effectively in a multi-discipline environment, and across cultures and levels of the organization
  • Proficient verbal and written communication skills; including experience in writing and presentation skills
  • BS in Engineering or Sciences
What We Offer

We offer a competitive salary of approximately €80,000 per year, depending on experience, plus additional benefits and flexibility that bolster your well-being and aid you in aligning your focus with what is personally and professionally important.



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