Medical Device QA / RA Manager - Rory Gummerson 02077587323

* Provide leadership, direction and guidance to project and departmental teams in regulatory and quality matters
* Ensure that all activities related to the production of medical devices and products are carried out within the parameters of the appropriate regulatory, legislative and company standards.
* To provide advice and reports to senior management regarding quality and regulatory issues associated with our clients products.
* Develop and maintain knowledge of current industry practices in regulatory affairs and update knowledge of regulatory requirements.
* Compile reports and regulatory submissions in compliance with statutory rules, regulations and guidelines.
* To be the main point of contact for liaising with regulatory consultants and ensuring relevant familiarity with other regulations E.g. Canadian and Japanese regulations, Biocide directive, Packaging and environmental requirements etc.
* Ensure all validation activities are performed in accordance with requirement and relevant timeframes.
* Customer complaint process is performed in accordance with requirements
* Act as coach and mentor and set good example to your team and other employees in the business

Experience:
* A science degree, Biomedical preferred
* Relevant professional experience in Quality Assurance specific to working within a medical device industry is required
* A thorough knowledge of FDA Quality System Regulations ISO 13485:2003, Medical Devices Directives and other applicable International Standards are required with experience of dealing with notified bodies and regulatory agencies directly,
* Proven and demonstrable experience of Equipment and Process validation experience is essential
* Strong analytical skills with emphasis on statistical analysis, pareto, structured problem solving
* Excellent skills in managing subordinates and strong interpersonal skills are required
* Must be able to handle multiple tasks/ projects and manage priorities accordingly
* Strong awareness of technical standards basic to a medical device company
* Knowledge of and exposure to manufacturing and engineering processes
* Ability to influence and make recommendations at all levels of the company

Education:
* Relevant experience in Quality Assurance and Regulatory Affairs in the Medical Device industry
* Relevant Leadership experience (People development, written and verbal communications skills, action/results oriented, impact and influence).

Personal Characteristics:
* Sound judgement with ability to balance big picture thinking and appropriate attention to detail, with a risk management focus
? Strong Strategic thinking and analytical skills
? Exceptional communication skills.
? High levels of initiative, self-motivation and energy.
? Excellent leadership and people management skills.
? Excellent project management skills; high attention to detail and follow-through on commitments

To find out more about Real Staffing please visit www.realstaffing.com