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JOB SUMMARY
As the leader of the regional RA and QA functions, this individual will manage a staff of regulatory and quality professionals to insure the quality and compliance of all products marketed in the region. This will include careful management of the distribution of self- manufactured, contract manufactured, and distribution of medical devices, in-vitro diagnostics devices and some pharmaceuticals. This individual will be the face of quality and regulatory to the internal organization, regulators and our customers for the region. In addition, he or she will represent the company in all regulatory conversations, assessments and negotiations on the licensing and quality of our products. The position will partner with the other regional heads of Quality and Regulatory, Europe and the Americas to address product quality, quality system, and regulatory licensing.
ESSENTIAL DUTIES
Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.
Enter Responsibilities/Essential Duties
Manages the Quality and Regulatory Staff to ensure efficiency and productivity, including meeting financial expectations
Responsible for licensing and maintenance of all products on market in the region, is the primary liaison with government agencies for regulatory and quality issues. Manages all regulatory interactions effectively.
Provides guidance to Regulatory staff in coordinating the preparation of regulatory submissions. Hands on preparation of documentation for product approval may be necessary.
Assists in the launch of all new product platforms in region by effective monitoring of the customer perceived quality
Stays abreast of all regional regulatory changes that could impact the efficacy of any product on market in the region
Liaise with global and local management to expedite preparation of documents required to gain regulatory product approvals.
Provides subject matter expertise and guidance to project teams through appropriate team participation and leadership.
Continuous monitor and ensures the quality of all products on market in the region
Responds urgently and effectively to quality or compliance concerns
Responsible for communication & oversight of Field Actions in the region.
Forms productive relationships with key customers.
Manages the quality aspects of a third party logistics distribution and refurbishment facility.
Manages the quality system and associated changes for the region.
Ensuring that the EMS conforms to the requirements ISO 14001.
Reporting the performance of EMS including environmental performance to top management
Continuous support to the development and implementation of program to achieve and maintain the ISO 14001 environmental management system.
Education Level Required/Preferred
Bachelor's Degree
Quality, Engineering, Science or Life science discipline or equivalent
Required
Experience Details Required/Preferred
5 years - progressive experience in both RA and QA roles in the market required
7 years - people management required
EEO Policy Statement
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