This global, innovative and expanding company specializes in the development, manufacture and marketing of transfusion diagnostics in order to improve patient's lives worldwide.

As the Regulatory Affairs Manager you report to the VP of Regulatory Affairs and hold a senior post within the company's regulatory affairs department where product licenses and all supporting documents are registered and maintained globally according to relevant regulations through clear communication with the regulatory authorities, venders and customer organisations.

Key Responsibilities:
*Participate in product development meetings
*Manage and support a team of regulatory officers
*Provide customers with relevant documents to enable registration
*Ensure all regulatory documents are compliant to regulations and standards globally
*Provide regulatory legislation expertise
*Manage the preparation of product license applications including IVD submissions, Biologics License Applications (BLA), Medical Device 510k Approvals and Premarket Applications (PMA)
*Liaise regularly with regulatory agencies and customers
*Compile product information
*Review analytical data
*Adhere to, implement and improve the company quality policy
*Assist with recruitment
You will possess a relevant medical, scientific or engineering degree, you must have 4 years global medical device and/or diagnostic regulatory affairs industry experience where you have worked to EU (CE) and US (FDA) regulations and previous exposure to submissions such as BLA, 510k, PMA, CE mark and technical files is essential. Additionally, leadership/management experience would be ideal. You should be a flexible and motivated natural leader who has excellent attention to detail, time management, communication and prioritization skills.
This is an amazing opportunity within a supportive and customer focused company where you will have the opportunity to make a difference. The successful candidate will be offered a competitive salary, a pension plan, life assurance, private healthcare, a generous holiday entitlement and a relocation package where applicable.

Key Words - Medical Device, Diagnostics, IVD, Immunohematology, Regulatory Affairs, Manager, Senior, Officer, Executive, Specialist, ISO 13485, ISO 9001, GMP, BLA, Biologics License, PMA, Premarket, Technical Files, EU, Europe, CE, Global, International, USA, US, FDA, Edinburgh, UK, United Kingdom
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