Our client is a global leader within the medical device field who possess a wide product portfolio with market leadership in various areas.
Due to a reorganisation within their business they are currently looking to recruit a Senior International Director of Quality And Regulatory.
Located in the EMEA headquarters in the UK the role will have the following key objectives;
- Conduct duties as the legally and formally appointed EC Authorised Representative for all Divisions and affiliates. Ensure and maintain compliance with post-market regulatory, quality and clinical requirements of the Medical Device Directive 93/42/EEC and in-county regulations. Assure all countries have the appreciate QA/RA oversight.
- Head up the end to end QA and RA responsibilities for Two manufacturing sites, one in the UK and the other in South America.
- Provide regulatory and quality support in relation to New Product Launch (NPL) processes, and Business Development (BD) activities including input to acquisition, due diligence and integration activities.
- Lead in driving the corporation and EMEA regions in ongoing compliance to current and new regulations and requirements and work closely between EMEA, US Divisions, Corporate, Notified Bodies, EU Competent Authorities, Ministry of Health and Trade Associations.
- Lead EMEA Quality and Regulatory team to include post market quality support and premarket regulatory support.
- Responsible for the talent management including recruitment, selection, development, training and retention of RA/QA staff across the EMEA locations. Ensure that proper Regulatory/Quality skills sets and competencies are consistent with business plans and technology development plans.
- Serves as an active participant of the EMEA Management Board to develop policies, strategies for business, and drive the QA/RA strategy; integrate RA/QA strategic initiatives in support of business initiatives
- Formulate and implement annual departmental goals, actions plans, and budgets according to Corporate and EMEA priorities. Oversee and lead monthly metrics reviews and quarterly Management reviews. Where appropriate and with EMEA management board, develop corrective and preventive actions or continuous improvements.
To be considered for this position our client is looking for individuals to have a minimum of 15 years’ experience within the QA/RA disciplines, a minimum of 5 years’ experience in a senior management role in the global medical device sector.
Due to the products you will be working with individuals will need to demonstrate prior working knowledge electro-mechanical products as well as diagnostics. You should also have strong International regulatory understanding including strong FDA experience.
The successful individual will be able to demonstrate a successful strategic background delivering improvements across a regional function, including the Emerging markets and has experience managing teams across Europe covering the Pre & Post market area of RA and QA.
It is essential for individuals to demonstrate strong leadership skill and a past history of building, developing and coaching teams whilst clearly understanding the fine balance between the regulatory and commercial challenges of the business.