Job Reference: J5632610
Updated On: 04/12/2019
Status: Open to Applications
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Role OverviewWe are currently looking for a Regulatory Affairs Advisor to join a leading Global Medical Device Company based in the Norfolk area. As the Regulatory Affairs Advisor you will be responsible for providing regulatory guidance on the design, development and commercialisation of the products. You will manage regulatory submissions and updates to ensure all licensing and registration requirements are met.
Key Duties and ResponsibilitiesYour duties as the Regulatory Affairs Advisor will be varied however the key duties and responsibilities are as follows:
1. Complete, maintain and deliver key regulatory documents, such as MHRA licenses and DMF submissions.
2. Work Closely with the Regulatory Authorities, internal and external customers, suppliers and laboratories to ensure information is compliant for audits and inspections.
3. To establish regulatory strategies for new products and manage regulatory submissions, maintenance and updates.
4. Manage medical device and medicines product life cycles in the EU and USA markets.
Role RequirementsTo be successful in your application to this exciting opportunity as the Regulatory Affairs Advisor we are looking to identify the following on your profile and past history:
1. Relevant degree in a science subject (E.g. Chemistry, Pharmacology, Biochemistry, Bioengineering) along side Industry experience in Regulatory Affairs.
2. Proven industry experience in Regulatory filing processes for Medicines and Medical Devices in the EU and USA market and product life-cycle management.
3. A working knowledge and practical experience with managing people, the manufacturing processes and Medicines and Medical Device commercial awareness in the USA and EU markets.
Key Words: Medical Device | Combination Products | Regulatory Affairs | Quality Assurance | Leadership | Management | EU | USA | Licensing | Regulatory Authorities | Life Cycle | Submissions | Medicines | Pharmaceutical | Documentation |
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