Current Vacancies

 

Are you interested in joining us in the development of novel panels of cancer biomarkers that enable more tailored patient management and ultimately improve the quality of life for cancer patients? Please get in touch today with your CV.

 

Current Vacancies

 

JOB TITLE: Quality and Regulatory Manager

REPORTING TO:  CEO

MAIN ROLE:

Management, Direction and Co-ordination of all quality and regulatory activities in the Company

 

RESPONSIBILITIES:

Maintain Quality System as per QS plan
Adapt existing Procedures and documents that best meet the requirements of QS and the work-flow within the Company. Create new Standard Operating Procedures, as required
Review and approve and have overall responsibility for Risk Management documentation and processes, in conjunction with Product Development Manager, as per OncoMark procedures
Interact and support Product Development and other staff to facilitate efficient use of resources in compliance activities
Carry out training and communication activities with staff to ensure adequate understanding of Quality Systems and Regulatory requirements
Develop and execute a Quality Audit Plan
Ensure adequate and suitable equipment and process validation procedures are in place and being complied with
Provide quality oversight of validation (and appropriate re-validation) of equipment, processes and control
Coordinate, in conjunction with the Product Development Manager, the overall coordination of each new product’s design and introduction to production
Review and approve Design and Development documentation as per OncoMark Design and Development Procedures  
Provide Quality and Regulatory inputs into Clinical studies
Interact with Regulatory Bodies to provide information on requirements for Certifications and approvals
Administer the change control, deviation and CAPA systems
Manage Manufacturing outsourcing and control, including review of Supplier Agreements, price negotiation, order placement, training on related procedures, approval of associated documentation and recommendations for process improvements
Update and implement, in conjunction with Product Development Manager, Health and Safety procedures and processes
Contribute to Senior Management team in the overall management of the Company
 

PRINCIPAL QUALIFICATION REQUIRED: Bachelor’s Degree in an Engineering or Science Discipline
 

WORK EXPERIENCE:

At least 6 years post graduation experience in Quality environment with at least 3 years at supervisory/ management level, within a Diagnostic/Medical Device Company
Excellent knowledge of an ISO 9001/2000 or ISO 13485 environment
Experience in the preparation of Technical Documentation
Experience in CAPA system management
A working knowledge of FDA requirements and managing FDA audits
 

KEY SKILLS:

Organisational and time management
Ability to work in a team 
Problem solving
Team leader and motivational skills
Listening, writing and oral communication skills
Presentation skills


PERSONAL ATTRIBUTES:

Highly self-motivated
Ability to work to deadlines and on own initiative
CONTRACT TYPE:  Permanent, full-time