Complaint Remediation – FDA MDR

Description de la mission

Complaint Remediation Specialist (FDA/MDR) – Zurich – 6 Month contract

Darwin Recruitment has a new vacancy at one of our clients located in Zurich where we are looking to hire a Complaint Remediation Specialist (FDA/MDR) to start as soon as possible.

General Conditions:

* Contract type: consultant / contractor / employed freelancer
* Location: Zurich 1 day per week / 4 days from home
* Duration: 6 months + extensions
* Hourly rate: CHF 100-120
* Start date: January 2024

Please note: This team has remote meetings and global project files, so the presence to be onsite in Zurich is only for onboarding and training.

Profile requirements:

* Bachelor’s degree preferred, or equivalent combination of education and experience
* 3+ years experience in processing complaints and performing investigations on remediation projects, ideally in the medical device industry
* Profound experience with reading and interpreting device diagnostics and troubleshooting with medical devices
* Background in Post Market Surveillance and Health Hazard Evaluation process
* CAPA process knowledge an advantage
* Proven experience in working with with complaint management systems (Service-Now, ServiceMax, SalesForce, etc.) as well as with Microsoft Dynamics 365 ERP system
* Speaks/writes/reads English (fluent or native)
* Good knowledge of German an advantage
* Profound experience with European medical device regulation (EU) 2017/745 as well as with American FDA laws and regulations
* Experience with communication to local authorities (FDA, SwissMedic, BfArM, …) a plus

Objective of position:

* The position owner is responsible for analyzing complaint data of a dedicated product or product group, in order to create complaint groups with same root cause and to provide investigation report to Vigilance
* She/he oversees all related processes and documentation and interacts with Vigilance department as well as Technical support team
* Further She/He ensures that complaint documentation and processing meet regulatory compliance and corporate standards
* She/He monitors process performance and reports progress on a weekly basis to project lead
* She/He groups internationally collected complaints into buckets

Professional competencies:

* Proven skills with European Medical Device Regulation (EU) 2017/747 and American FDA laws and regulations
* Computer literacy; familiarity with information technology concepts, personal computers, Microsoft Windows operating system and Microsoft Office applications.
* Familiarity with Complaint Management Systems (Service-Now, SalesForce ServiceMax, …) as well as ERP systems and related service productivity/reporting software applications.

Interested? Please reply to this advert with your CV and I’ll contact you to discuss.

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Darwin Recruitment AG is a Zurich based, SECO licensed, privately owned subsidiary of Darwin Professional Staffing Group Ltd (a Global IT Recruitment Consultancy).

Darwin Recruitment AG manages client relationships whilst also utilising Darwin Professional Staffing Group databases and networks to source Candidates and fulfil client requests.

We do not ask for a placement fee from Candidates/Employees.

If you wish to contact a specialist regarding this role, or your job search in general, please contact +41 (0)43 456 29 09