Closing Date: 21 Dec 16
Salary (£): Negotiable
Quality Engineer & Regulatory Affairs (f/m) in Bonaduz Our client is responsible for the intensive care of patients worldwide. They are renowned for their ease of use and their intelligent and automatic adjustment to the patient's needs. The development of the products as well as the manufacturing is taking place in the Region of Bonaduz in Switzerland and afterwards marketed worldwide. ...
Quality Engineer & Regulatory Affairs (f/m) in Bonaduz
Our client is responsible for the intensive care of patients worldwide. They are renowned for their ease of use and their intelligent and automatic adjustment to the patient's needs. The development of the products as well as the manufacturing is taking place in the Region of Bonaduz in Switzerland and afterwards marketed worldwide.
To strengthen the multinational team we are looking for the following qualification:
* Respond to regulatory authorities’ requests for additional Information.
* Participate in product teams developing new products to define global regulatory requirements.
* Interface with International Regulatory Affairs Team to support preparation of dossiers for registration for other international markets such as Japan, the Far East, Australia and Latin America.
* Keep abreast of changes and proposed changes to the worldwide regulatory requirements related to our products and processes.
* Assist in the development and maintenance of regulatory procedures to assure consistent, efficient and compliant regulatory processes.
* Assist with compliance activities related to FDA regulations and ISO quality system Standards.
* Develop, coordinate, prepare and maintain US medical device submissions such as 510ks, PMAs, IDEs and applicable supplements and annual reports and liaise with FDA reviewers as needed.
* Develop, coordinate, prepare and maintain Canadian Class 2, 3 or 4 Device License submissions.
* Bachelor's Degree is required, preferably in engineering or life sciences.
* Minimum of 3 years regulatory affairs experience in the Medical Device industry is required.
* Experience with 510(k) submission and/or PMAs.
* Ability to work in small team environment, but also self- starter with ability to work independently is essential.
* Must be able to meet deadlines and be detailed orientated.
* Good planning and organization skills are a must.
* Strong critical thinking and problem solving skills are preferred.
If you are interested, please contact me, Petra Ognjenovic as follows: firstname.lastname@example.org
In case of any further clarification needed, please call me, Petra Ognjenovic as follows: +49 89 2109 4906.
Keywords: Regulatory Affairs, Quality Management, Medical Devices, Zulassung, Medizintechnik, DIN EN ISO 13485, Petra Ognjenovic, in Vitro Diagnostik, Lawrence Harvey, Qualitätssicherung, Qualitätsmanagement
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