Medical Device

I am seeking project work in the field of Medical Devices.
I have experience in the area of development, regulatory affairs and quality assurance.

• DIN EN ISO 13485

I am relocating to Munich from the UK and I would like to work in the medical device area. I have experience in technology, regulatory affairs and quality.
In my role as regulatory affairs officer I was the first member of the regulatory team. The role required me to set up all the process, procedures and documentation required to place a CE marked product on the market. Under pressure I had to work independently and to a high level of accuracy to achieve the task. The product was successfully launched on time and the documentation externally audited to check the standard.
As a company first I have worked on the documentation for a clinical trial for a class II I medical device product. The development of this documentation required multiple interactions with internal and external stake holders. I set up meetings with notified bodies, competent authorities, FDA, clinicians and potential sites. I am comfortable working to procedures and processes and feel I have the necessary skills to review and track regulatory and investigator documentation to the required directive and guidelines. I have the ability to review and analyse relevant data so as to assist in building evidence based clinical trial strategies. In my current organisation I have written numerous clinical evaluations and I have assisted in developing clinical evidence building strategies in different medical device fields.
Throughout my career I have held numerous roles where the balance of independent to team working has shifted. I am comfortable with completing tasks to deadlines and working under pressure. Currently I work on multiple projects. These projects are multi-functional and require strong organisational skill so that all team members are clear about their role and responsibilities. I am used to managing multiple projects at the same time and comfortable with prioritising tasks and managing my time effectively to meet deadlines and business requirements. In all aspects of my like I like to feel a sense of achievement. In general I feel this achievement by meeting my own targets and tasks- I am very self-motivated. This self-motivation makes me organised and a good problem solver as I like to complete what I set out to do.
Over my working career I have developed good communication skills both written and oral. I understand the need to communicate in different ways and to tailor your communication to the audience. I pride myself on working to certain values and integrity is one of them. I am a trusted member of staff and treat everyone with respect and as how I would like to be treated.
I am a native speaker of English and I have a very good command of French and Italian I have started to learn German recently since the decision to relocate to Munich. Occasionally in my current role I use my languages to communicate with customers and colleagues as we are a global company.
In my current role and organisation I work with MS Office on a daily basis and feel very comfortable with it. The organisation has recently installed a new complete business system (Microsoft AX Dynamics) and I worked with the development team to help set up the processes and some of the master data.
I have worked in my current organisation for ten years and I feel I have developed the experience and knowledge that would help me to be successful in project work.

Completed - Post Graduate Certificate in Quality Management & Regulatory Affairs (HCS)
Sept 1999 - June 2002 The University of Birmingham
Bsc Biochemistry (Awarded 2:1 Hons)