Regulatory & Compliance Consultant
CK QLS are recruiting for a Regulatory & Compliance Consultant to join a Global Medical Device company at their site based in Solothurn on a contract basis until the end of 2020, with the possibility of extension.
Regulatory & Compliance Consultant Role: The main purpose of the role will be to ensure effective business wide compliance program that meets requirements for the medical device business. Through partnering with compliance leaders from the EU region to ensure overall compliance through internal audit process, your responsibilities will include:
- Conducting and leading Internal Audits and assessing 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.
- Ensuring proper internal audit reporting, response review and approvals, communication of issues.
Further responsibilities willinclude:
- Collecting metrics data from sites.
- Supporting Compliance improvements, which result from audits, Quality Board Issues and other system indicators.
Your Background: In order to be considered for this role, you will be required tohave 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 ina quality and/or compliance function as well as leading performing audits is required.
The role could involve some travel, mainly around Switzerland.
This is an excellent opportunity to join a global leading medical device company.
Apply:For more information or to apply for this Regulatory & Compliance Consultant position, please contact Adrien on 0041 (0) 78 250 85 35 or email aguimard@ckqls.ch, quoting job ref 49028.
Please could you send any correspondence in English.
It isessential that applicants hold entitlement to work in Switzerland.
