Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Pharmiweb.com RSS Feed PharmiWeb Candidate Blog

Pharmiweb.com RSS Feed PharmiWeb Client Blog

Job Details

QA/RA professional - Central Switzerland

Company: Hobson Prior
Location: Switzerland
Reference: MO986585
Closing Date: 23 Jan 17
Type: Contract
Salary (£): On Application
Benefits: Depending on experience

Job Summary:

My client is a leading specialist in digital imaging. As the QA/RA Professional you will ensure quality, regulatory compliance and safety and efficacy of our products and medical devices. Being a member of the development project core teams you will provide guidance and define regulatory plans and strategies.

Requirements:

My client is a leading specialist in digital imaging. As the QA/RA Professional you will ensure quality, regulatory compliance and safety and efficacy of our products and medical devices. Being a member of the development project core teams you will provide guidance and define regulatory plans and strategies. You will be accountable for the implementation of the premarket regulatory procedures, sound application of risk management principles and the compilation of documentation to achieve timely regulatory clearances. At your site you furthermore are supporting the divisional quality system as part of our integrated management system.

You are responsible for:

Assuring regulatory and process conformance for development and maintenance projects as member of cross functional premarket project core teams.
Definition of a Regulatory and Product Quality Strategy
Creation and maintenance of key regulatory deliverables of the projects
Regulatory and CE submissions in cooperation with regional QARA organizations
As risk moderator of development team ensuring that the medical device risk analysis process is followed
Reviewing product documentation to ensure compliance with regulations and signing off on key project related documentation and milestone
Providing compliant design control files and defending pre market activities during external regulatory inspections
Taking actions on process issues for related premarket/design control processes
Identify ongoing training needs and provide training as required
Provide KPI data for internal reporting on project status and regulatory submissions
Supporting the Integrated Management System on site. Performing internal audits as per the global internal audit plan and support external audits
 

Profile: 

At least 3-5 years’ experience in a regulated industry – preferably medical device, holding a position in quality assurance, regulatory affairs, quality management or project management
Subject matter expert in regulatory affairs with in-depth knowledge of relevant Healthcare quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive 93/42/EEC
Operational experience with risk management processes
Ability to analyze, understand, and interpret regulations and quality standards for a more general business audience
Self-starter attitude, strong organizational skills and the ability to meet deadlines
Team player with excellent communication and leadership skills, capable of coaching
Very good German and English verbal and written communication skills, French language is an asset

 

Please use the form below to apply or contact us for further information on the position. Alternatively, if you know someone that would be interested and suitable, you can refer a friend!

 

 

 

 

 

Apply here - applying is quick and easy on our new website

Apply for this job: QA/RA professional - Central Switzerland

Contact Information:

Address:  Hobson Prior Europe GmbH
D4 Platz 3
6039 Root Längenbold
Luzern
Switzerland
CH-6039
Switzerland
Tel:  t: +41 (0)41 455 25 60
Fax:  f: +41 (0)41 455 25 61
Website:  Visit Our Web Site

Advertising
Share | | |
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.