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 the Company's Quality Management System
- 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
- 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 5 years post graduation experience in Quality environment with at least 2 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
- An understanding of FDA QSR requirements
 

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, part-time