Vice President,Regulatory Affairs/Compliance
Posted on Jan 17, 2019 by CyberCoders
You will be responsible for setting the strategic direction and leading the overall regulatory and compliance teams to success. The Vice President, Regulatory and Compliance will offer strategic project contribution, in addition to establishing standards and implementing procedures to ensure that the business units quality management and compliance program is effective and efficient in identifying, detecting, and correcting non-compliance. Will look ahead at the changing regulations and be an enabler to create a culture of quality across the organization. The Vice President Regulatory Affairs and Compliance will provide guidance and work jointly with the senior leadership team and key stakeholders to ensure compliance and regulatory goals are met while also achieving excellence.
- Experience as a senior manager within a large matrix-managed organization, including supervision/management experience.
- Regulatory Affairs or Quality Assurance experience in a regulated industry, including experience in agency inspections and external audits.
- Experience working across cultures/countries/sites.
- Experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
- Knowledge of FDA QSR, ISO13485, ISO14971, IEC62304, MDD 93/42/EEC.
- Medical Device experience is a must, and dealing with these standards is a minimum requirement.
- Experience in building infrastructure to support the business strategy.
Sterling Life Sciences
CHATTANOOGA STATE COMMUNITY