J5631103HampshireBiotechnology Medical Devices PermanentIndustry CompetitiveFull Time12/03/2019Microbiology Regulatory Affairs Regulatory Affairs – Global New Product Introduction Management
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A new opportunity for an experienced Regulatory Affairs professional with a focus on Medical Device strategy at an International level has become available to join a Global Life Sciences company. This position is located in the South of the UK and can be based from any of their offices in Hampshire, West Sussex or Kent.
This is a senior level position with line management responsibilities. As the International Regulatory Affairs Manager you will be expected to lead the International strategy for IVD and Medical Devices. You will influence internal stake holders and ensure the successful submission of novel licences.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the International Regulatory Affairs Manager will be varied however the key duties and responsibilities are as follows:
1. Line Management - You will lead a small team of Regulatory Affairs professionals focused on increasing the market access of clinical diagnostic products through successful pre-market licences. You will ensure that your team follow company strategy in an accurate and timely manor.
2. Strategy - You will assist with the development and execution of Internationally focused strategy for IVD (In-Vitro Diagnostic) Medical Devices. Regions will include the EU, US and Asian markets. By generating regulatory intelligence and using your product knowledge and understanding of technical data, you will ensure the successful submission of licences to a range of markets.
3. Life Cycle Management - You will ensure that existing Global product licences are maintained through the timely submissions of Variations and Renewals.
4. Collaboration - You will work cross-functionally with a range of departments including R&D and Commercial teams and will influence internal and external stakeholders and key opinion leaders.
To be successful in your application to this exciting opportunity as the International Regulatory Affairs Manager we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences Discipline (e.g. Biology; Biotechnology; Chemistry; Medical Device focused degree etc.) in additional to extensive International Regulatory Affairs experience within Medical Devices or IVD industry.
2. Proven industry experience in leading a team of Regulatory Professionals where you are ensuring KPIs are met and important project timelines are maintained.
3. A working knowledge and practical experience with International Regulatory Affairs Strategy development for Medical Devices or IVDs.
Key Words: Regulatory Affairs | Medical Devices | In Vitro Diagnostics | IVD | IVDs | Strategy | CE Marking | Global | International | Regulatory Intelligence | Clinical Diagnostics |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.