R&D Risk Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

21st September 2018

Location

Switzerland

Salary/Rate

£115 - £116

Type

Contract

Start Date

01/11/2018

This job has now expired please search on the home page to find live IT Jobs.

R&D Risk Manager

Industry: Pharma/Medical Device

Duration: 01/11/2018 to 01/11/2020

Location: Basel-Land

Main responsibility:

* Lead specific risk management activities within projects, as agreed with project leaders

* Timely completion and ensure quality of the assigned risk management file for Medical Device

* Facilitate development and completion of risk assessments

* Ensure compliance with ISO 14971 in all development projects assigned

* Conduct and provide guidance on the use of risk analysis for Use, Products, Components and Processes

* Ensure compliance with regulatory and normative guidelines focusing on medical device risk management

* Guide internal and external functions on creating, reviewing and approving medical device Risk Management Files

* Work with device development team to incorporate and complete Risk Management during all design phases for new and/or product enhancements

* Apply FDA CFR 820, ISO13485, and ISO 14971 Risk Management in assigned projects Author the documentation in the medical device risk management file.

* Support DRA to prepare Medical Device/Combination Product pre-registration documents and answer health authority questions.

*

Requirement for the role are:

* At least 5 years of experience in device development of parenteral delivery systems, e.g., drug/device combination products with main focus on medical devices

* The ideal candidate would have experience generating DHF documentation.

* Excellent technical writing skills (e.g. DHF, Design Controls, Verification)

* Good understanding of medical device regulations ISO13485, (FDA 21CFR 820, EU Medical Device Directive) and of combination products (US)

* Experience in Product Design and Design for Manufacturing

* The ideal candidate has good technical knowledge of primary containers development, good technical knowledge of auto injector development

* General understanding of Human Factors Engineering and usability

* General understanding of clinical trial processes and requirements

* General understanding of pharmaceutical development

*

Should you be interested in this or similar poistions within Medical Devices, please feel free to get in contact with me or send me your latest CV to; s.keel(at)realstaffing.com

Kind Regards

Sabina Keel

Senior Recruitment Consultant

Medical Devices Pharma & Biotech

Real Ein Geschäftszweig der SThree GmbH Claridenstrasse 34, Zurich 8002, Switzerland ------------------------------------------------

T: +41 (0) 44 588 2627

E: s.keel(@)realstaffing.com

-------------------------

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.

You are currently using an outdated browser.

Please consider using a modern browser such as one listed below: