Consultant Regulatory & Compliance
Posted on Oct 9, 2020 by Harvey Nash IT Recruitment Switzerland
For our client in Zuchwil we are looking for a Consultant Regulatory & Compliance for a 3 months project.
Consultant Regulatory & Compliance based in Zuchwil, Switzerland
Mission until EOY, very likely to be extended
The consultant Compliance Specialist ensures effective business wide compliance program that meets requirements for the medical device business. This position will partner with Compliance leaders from the EU region to ensure overall compliance through internal audit process.
This individual will collaborate with the Source compliance team and EU Compliance team and all levels building partnerships to further our compliance organization in its goals and objectives.
Through his/her experience, qualification and expertise, the consultant compliance specialist will participate to maintain Source strategic collaborator and our quality system processes in compliance with ISO13485, FDA QSRs and the EU MDR and other applicable regulations and standards.
Further responsibilities and duties are:
* Conduct and lead Internal Audit as per company Internal Audit schedule and assess compliance with local, national, international and company regulations, policies and procedures
* Support inspection readiness plan within EU region against EU MDR in high collaboration with site compliance partners and business partners.
* Collect metrics data from sites.
* Use of tracking and trending tools in order to share proactive trends/signal to the compliance leader.
* Support Compliance improvements, which result from audits, Quality Board Issues and other system indicators
* Work effectively with the Source Compliance team and other site compliance specialist to ensure consistent systems across the organization.
* Ensure proper internal audit reporting, response review and approvals, communication of issues.
* When required assist given facilities for both external audit preparation and assistance during their external audit
* Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485/EU MDR) within a regulated environment
* At least 5 years working experience in a regulated Medical Device industry
* Experience in a quality and/or compliance function as well as leading performing audits is required
* Excellent Communication Skills (written & oral) in English - German would be a plus
* Excellent Team Player
* High Sense of Urgency
* Available to travel (mostly within Switzerland)
For more information please contact Barbara Tenerowicz:
E: (see below)
T: (see below)