We are looking for the Regulatory and Compliance Manager for Depuy Synthes who will Lead Compliance activities in the EU region to achieve a compliance framework that focuses on oversight and execution in a detailed way to enable proactive compliance success in delivering business needs across operating units.
Your main responsibilities will be to provide leadership, oversight, and strategic guidance for Regulatory & Compliance issues for the team and site the compliance manager is responsible for.
In this role you will collaborate with US and OUS compliance team to standardize and bring to bear compliance initiatives, practices and metrics across the organization.
You will be required to enable successful product realization and compliance through readiness compliance activities, assessments and other consultation, as well as be the Compliance Point of contact and provide leadership / oversight of inspection readiness, audit management, and responses for internal and external inspection.
- To Run compliance activities to reach GO Compliance goals and objectives
- To drive and support internal audit efficiency program
- To lead and support the inspection readiness program
- To Build good relationship and partnership with partners
- To be the point of contact for notified body
- To support site external inspection (provide assistance in Front Room/Back Room during external audit)
- To act as Subject Matter Authority on internal audit process for any site external inspection
- To provide expertise and support in site response, when applicable, for 3rd party, notified body or corporate inspection
- To track 3rd party, notified body or corporate inspection commitments timeliness and to inform regularly local/regional management accordingly
- Work effectively within the OUS and US compliance teams
- Work effectively with site business partner in a collaborative approach
- Talent development
- Graduate degree/studies in science, business, engineering or organizational management or equivalent experience strongly preferred
- Equivalent degree and/or adequate associated work experience is acceptable
- Your qualification as lead auditor and experience in leading internal audit will be important
- At least 6-8 years working in a regulated industry with a 3 to 5 years experience in a quality and/or compliance function
- Experience in a Medical Device or Pharma company
- Extensive knowledge of Quality Systems (21 CFR 820/ISO 13485) within a regulated environment
- Experience in leading internal audits is required
- Experience with external inspection associated with Medical Devices or Pharmaceuticals is required (Health authorities inspection i.e FDA, TGA.. or any Notified Body audit environment)
- Proven experience with People Management and development
- Change management and project management experience
- Experience in Handling complexity and issue remediation
- Excellent organizational and communication skills (written and verbal)
- Excellent soft skills when working with others up, down and sideways within DePuySynthes, with consultants and with suppliers
- Strong influencing skills and a standout colleague
- You may have limited travel within EU (10% of your time)
- English language requirement: fluent, German: Very Good
Synthes GmbH (7111)