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Regulatory Consult - Active Medical Devices

Workscope: Consulting ·  Regulatory Affairs

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We have been an independent service provider for the agrochemical, industrial chemical and pharmaceutical
industry since 1996, with currently over 490 employees at sites in the EU, Asia and the USA. As a leading service provider with an international focus, we offer comprehensive advice on the registration of agrochemicals, biocides, industrial chemicals, veterinary pharmaceuticals, medical devices and biotechnological pharmaceuticals.
 
 
To support our Health Care team we are currently seeking as soon as possible a
 
   Regulatory Consultant (m/f) - Active Medical Devices
   Ref. No. 2016-28/JV
 
 
Role and Responsibilities
  • Preparation of regulatory documents in compliance with regulatory standards
  • Auditing according to EN ISO 13485 and 93/42/EEC or 90/385/EEC (Focus on active medical devices)
  • Developing / compiling technical files and design dossiers
  • Maintenance of contacts with the clients and regulatory authorities (e.g. Interactions with notified bodies)
  • Strategic planning and preparation of regulatory submission documents, interpretation of regulations and
    compliance with regulatory guidance
  • Support of the management with implementation of strategies and policies

Profile and Qualifications
  • Educated to degree level (engineering / Master of Science) or with an equivalent combination of qualification and experience
  • Strong knowledge of regulatory guidelines: Medical Device Directive (MDD) – Directive 93/42/EEC and
    amendments and EN ISO 13485, EN ISO 14971, EN ISO 10993 series , EN 60601-1, EN 62304, EN 62366, etc.)
  • Working experience of at least 3 years in the Medical Devices sector
  • Excellent interpersonal, verbal and written communication skills as well as a strong customer focus
  • Excellent language skills in German and English (spoken and written); additional language skills would be an asset
  • Ability to manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
  • Ability to travel locally and internationally as well as ability to work at the client’s site, as required

Benefits
 
You will be working in a modern, professional, fast-growing, internationally-active organisation with a high degree of responsibility and independency. Intensive on-the-job training will be provided in a competent multidisciplinary team.
 
Location:      Mannheim, Berlin or Leverkusen (Germany)
 

Contact detail


How to apply:
Please submit your complete application in English or German, including a detailed Curriculum Vitae, salary expectation and availability by e-mail to application@knoell.com
 
Send application to
Dr. Knoell Consult GmbH
Human Resources
Dynamostr. 19
D-68165 Mannheim
www.knoell.com
e-mail to application@knoell.com
 

Job profile


Working hours
Full-Time
Contract duration
Permanent
Type of job
Specialist
Work experience
job experience is not required
Region
Germany (Baden-Württemberg, Berlin, Nordrhein-Westfalen)
Working place
68165 u.w. Mannheim, Berlin or Leverkusen
Area of expertise
Healthcare & Public Health, Chemical & Process Engineering, Medical Engineering
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