Job Reference: J5631427
Updated On: 02/05/2019
Status: Open to Applications
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Role OverviewA exciting opportunity for a Regulatory Affairs Assistant has become available in a leading Medical Device company based just north of Cambridgeshire. As the Regulatory Affairs Assistant you will support regulatory submission through the co-ordination and maintenance of Regulatory files including DMFs, 510(k), Technical Files MAF and site Master files.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Assistant will be varied however the key duties and responsibilities are as follows:
1. Complete, maintain, own and deliver all regulatory documents, e.g. MHRA licences, DMF etc. as well as maintaining drug and device registrations with the FDA to ensure they are up to date to enable the company to continue supplying product to the US market.
2. Work closely with Regulatory Agencies including the MHRA, FDA and Canada Health. You will assist with customer visits, audits and Regulatory Authority inspections.
3. Provide direction, advice, training and guidance to employees regarding compliance and regulatory issues, including the review and implementation of QMS transactions (notifications, change controls etc.).
4. Maintain up-to-date knowledge of relevant regulatory legislation and guidelines specific to the company's new and existing programmes to ensure regulatory requirements are compliant and continuous improvement in Regulatory Affairs processes and procedures.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Assistant we are looking to identify the following on your profile and past history:
1. Relevant degree in a Life Sciences discipline e.g. Biology, Chemistry, Pharmacology, Pharmacy etc. in addition to prior Regulatory Experience from current position or industry placement.
2. Knowledge of EU and USA Regulatory Filing process for medicines and/or Medical Devices.
3. Proven ability to work in a face paced environment where you have worked accurately with excellent organisational skills; managing time and adapting when necessary.
Key Words: Regulatory Affairs | Assistant | Associate | Officer | Medical Device | Combination Drug Products | DMF | 510(k) | Technical Files | Master files | MHRA | FDA
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