Regulatory And Compliance Consultant
Jocelyn Blackham is recruiting for a Regulatory and Compliance Consultant to join a leading company in the medical device industry at their site based in Zuchwil on a contract basis until July 2020.
The main purpose of the role will be to:
- Ensure effective business wide compliance program that meets requirements for the medical device business
Partner with Compliance leaders from the EU region to ensure overall compliance through internal audit process.
Collaborate with the Source compliance team and EU Compliance team and all levels building partnerships to further the company's compliance organization in its goals and objective
- Maintain Source strategic collaborator and company quality system processes in compliance with ISO13485, FDA QSRs and the EU MDR and other applicable regulations and standards.
Further responsibilities will include:
- Conducting and leading Internal Audit as per company Internal Audit schedule and assess compliance with local, national, international and company regulations, policies and procedures
- Supporting inspection readiness plan within EU region against EU MDR in high collaboration with site compliance partners and business partners.
- Collecting metrics data from sites.
- Use of tracking and trending tools in order to share proactive trends/signal to the compliance leader.
- Supporting Compliance improvements, which result from audits, Quality Board Issues and other system indicators
- Working effectively with the Source Compliance team and other site compliance specialist to ensure consistent systems across the organization.
- Ensuring proper internal audit reporting, response review and approvals, communication of issues.
- When required assisting given facilities for both external audit preparation and assistance during their external audit
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485/EU MDR) within a regulated environment
- Previous 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 or to apply for this position, please contact Jocelyn Blackham on 0041 (0) 782 516 595 or email jblackham@ckqls.ch. Please could you send any correspondence in English. Please quote reference 46974 in all correspondence.
