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Clinical Affairs, Regulatory & Medical Writing Manager Medical Devices (m/w/d)

Date: May 31, 2021

Location: Dresden, SN, DE, 01277

Company: Heraeus

[title]
Clinical Affairs, Regulatory & Medical Writing Manager Medical Devices (m/w/d)
Location Dresden
Permanent 
Full Time
 

Imagine a job where you will have the opportunity to do exciting and challenging work, while collaborating with extraordinary colleagues. A company that invests in you and your career, providing the training, mentoring, development and support you need to be successful now and in the future. If you want a career without limits with a market-leading family-owned, global company where you can make an impact, then imagine an opportunity at Heraeus. Every day, our worldwide team of approximately 14,900 employees are bringing forward new ideas and solutions that are impacting and transforming everything from healthcare to renewable energy to e-mobility to high-tech and telecommunications.

 
 

Your role and responsibilities:

  • In this function you are the regulatory & clinical subject matter expert for new and innovative medical devices that are being developed on the site..
  • You are responsible for performing literature and market searches, creating clinical evaluations according to MEDDEV 2.7.1 and clinical investigation documents.
  • In this role you provide clinical input and feedback during the product development cycle.
  • As our inhouse expert you provide device-related clinical and regulatory consulting and guidance to customers and staff.
  • Based on your professional background you provide support to customers in clinical investigations.
  • You create and defend regulatory submissions and approvals (CE mark technical documentation, US FDA filings, other country registrations, clinical investigation submissions to medical ethics committees and competent authorities).
  • It is your passion to train staff on clinical and regulatory activities and to support internal and external audits
  • You control and perform Post Market Surveillance activities.
  • You will be responsible for leading one colleague, who will be supporting you on your activities.
  • On regular bases you contribute to the creation and execution of Corrective Action Preventative Actions.

 

What is required for this role:

  • You have an university degree with medical or scientific backround or an engineering PhD degree
  • You bring more than two years experience as a professional in clinical/regulatory area, preferably in medical devices, pharmaceuticals, biotechnology
  • You understand the ISO 13485, MDR 2017/745 and 21 CFR part 820 and related requirements
  • You communicate excellent (written and spoken) in English, German language skills would be beneficial
  • You have excellent literature research skills
  • Within a growing organization leadership or team lead experience is required.
  • An independent and autonomous working style supports your success in fulfilling your tasks