Randstad Professionals is currently looking for a Consultant for Regulatory and Compliance who will be assigned an interesting challenge for a top Medical Device manufacturer in the canton of Solothurn
Our client offers an initial contract until End December 2020. This assignment is very likely to be extended in 2021. in a very challenging environment. This is a fantastic opportunity to join a top class company.
This contract will take place within the Regulatory Compliance Organization of this major Medical device manufacturer.
Scope of the assignment:
The 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.
You will collaborate with the Source compliance team and EU Compliance team and all levels building partnerships to further our client’s compliance organization in its goals and objectives.
Through his/her experience, qualification and expertise, the compliance specialist will participate to maintain Source strategic collaborator and the 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.
• 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
• Available to travel (mostly within Switzerland)
If you are interested to learn more about this great opportunity, don’t hesitate to get in touch with me. Feel free to send me your CV at following email
I am looking forward to receiving your applications
Randstad Professionals Basel