CH - Compliance Auditor - Normal

A globally renowned pharmaceutical company is seeking to recruit a CH - Compliance Auditor - Normal to their office in Switzerland. The organisation works across a range of industries, from medical devices to pharmaceutical and consumer goods, and operates in over 60 countries. This position offers an exciting opportunity to work with a prestigious and historic pharmaceutical establishment and provide real regulatory expertise.

Job Responsibilities:

• Creating an effective business wide compliance program that meets requirements for the medical device business.
• Partnering with Compliance leaders from the EU region to ensure overall compliance through internal audit process.
• Collaborating with the Source compliance team and EU Compliance team at all levels building partnerships to further the company's compliance department in its goals and objectives.
• Maintaining Source strategic collaborator and company quality system processes in compliance with ISO13485, FDA QSRs and the EU MDR, and other applicable regulations and standards.
• Conducting and leading Internal Audit as per company Internal Audit schedule 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.
• Collecting metrics data from sites.
• Using 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.

Skills and Requirements:

• 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).
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.

• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact James Wilson at +44 203 762 2703 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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