Our client is the largest, most comprehensive orthopedic and neurological business in the world. Their broad array of inspired, innovative and high-quality offerings helps advance the health and wellbeing of people around the world. On their behalf, we are looking for a
Consultant Regulatory & Compliance
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 internal 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 internal quality system processes in compliance with ISO13485, FDA QSRs and the EU MDR and other applicable regulations and standards.
Your main tasks:
- Creation of protocols and reports for IQ, OQ, PQ, Test Method Validation (TMV) or Software Validation
- Collaborate with other departments (Manufacturing, Engineering, Inspection, logistics) to ensure proper execution of the validation and the tests
- Be able to lead small projects on a timely manner
- 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
- Available to travel (mostly within Switzerland)
Start: ideally October 2020
Duration: until the end of 2020 - very likely to be extended
Workload: 100% (40h/week)
Please apply online. For further information about the position, please contact: Mrs Diana Steinhauer (+41 61 270 80 16).
We are looking forward to getting to know you!