Job Reference: J5632821
Updated On: 13/02/2020
Status: Open to Applications
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Role OverviewWe are currently looking for a Medical Device Regulatory Expert to join a leading Pharmaceutical company with a Medical Device portfolio, based in the Middlesex area. As the Medical Device Regulatory Expert you will be responsible for being the internal Subject Matter Expert on the regulations and regulatory requirements for Medical Devices including IVDs and Active Implantable devices.
Key Duties and ResponsibilitiesYour duties as the Medical Device Regulatory Expert will be varied however the key duties and responsibilities are as follows:
1. Act as Subject Matter Expert for Brand Teams and cross functional Medical Device project teams where you will provide expert advice and support, especially in relation to due diligence projects.
2. Maintain an up to date knowledge of relevant regulations, guidelines and industry standards in regards to Medical Device products.
3. Explore opportunities for continuous improvement of internal processes to ensure compliance.
4. Work closely with the Regulatory Affairs Manager and deputise as required.
Role RequirementsTo be successful in your application to this exciting opportunity as the Medical Device Regulatory Expert we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline in addition to extensive Medical Device experience with a focus on the Regulation, MDD and MDR.
2. Proven industry experience in the development, certification and maintenance of Medical Device Products.
3. Ability to work in a collaborative environment where you offer expert advise to a wide range of teams and people with ability to communicate clearly with internal and external stakeholders.
Key Words: Regulatory Affairs | Medical Devices | MDR | MDD | In-Vitro Diagnostics | CE approval | Subject Matter Expert
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