Connecting...

W1siziisinrozw1lx2fzc2v0cy9zy2lwcm8vanbnl2pvyl9kzwzhdwx0x2jhbm5lci5qcgcixv0

Regulatory Labelling Manager (m/f) in the Area of Zug

Regulatory Labelling Manager (m/f) in the Area of Zug

Job Title: Regulatory Labelling Manager (m/f) in the Area of Zug
Contract Type: Permanent
Location: Zug
Industry:
Salary: Negotiable
Start Date: ASAP
Reference: SPPO1705_1495042752
Contact Name: Petra Ognjenovic
Contact Email: p.ognjenovic@sciproglobal.de
Job Published: May 17, 2017 18:39

Job Description

Regulatory Labelling Manager (m/f) in Baar

Our clients is an internationally leading Medical Technology Company who offers an exciting tailored career path for your professional and personal development within their Regulatory Affairs & Quality Assurance team. The client is specialized on heart diagnosis, monitoring as well as software solutions. The manufacturing takes place in Switzerland and the products are distributed worldwide.

Tasks:

  • Coordinating global regulatory affairs functional activities to ensure effective support to achieve existing plans and objectives
  • Manage and be responsible for regulatory label compliance e.g. UDI requirements
  • Manage international regulatory submission process through to approval, including management and coordination of preparation of all regulatory documentation
  • Close cooperation with local regulatory representative e.g. in Asia Pacific region and Latin America for product registration
  • Support distributors world-wide for product registration
  • Involved into change assessment process
  • Be a part of review process for labelling and marketing documents
  • Support regulatory training
  • Keep up-to-date with the current regulatory environment (medical device)

Requirments:

  • Fluent in English, German is a plus
  • Experienced in international medical device environment and familiar with active medical devices
  • In-depth know-how of regulatory labelling including UDI
  • Experienced with CE-marking and international registration process. FDA 510(k) and PMA submission, experience is a plus
  • Good organizational and planning skills
  • Good communication skill with local regulatory representatives and distributors

Are you motivated, committed and flexible? Do you enjoy taking the initiative and working independently? Do you have a highly developed quality awareness? Do you work conscientiously, and are you resilient to stress? Then please send your complete application documents by email to Petra Ognjenovic: p.ognjenovic@sciproglobal.de

In case of any further question, please do not hesitate to contact
Petra Ognjenovic: 0049 89 2109 4906.