Regulatory Affairs Officer

15 May 2017
12 Jun 2017
Abi Bendinger
Contract Type
Full Time
This role involves developing and implementing strategies to introduce new products to the international market. The successful candidate will develop, create and manage a portfolio of Technical Files and Licenses. It will be required to review proposed labelling and marketing materials prior approval for use.

Duties include:

* International Registrations and European Directives: Develop and coordinate a program to ensure all registrations are completed to agreed time scale
* Support a roll out program for existing products and new launches.
* Manage the creation and development of Technical Files in compliance with the Medical Devices Directive.
* Responsible for advising/supporting customers to assure the continued Regulatory Compliance of existing products throughout their life cycle
* Review proposed marketing materials, packaging, Instructions For Use and Label copy for Regulatory compliance
* Manage a program to ensure efficient scheduling of registrations to meet commitments established for development project plans
* Assure continued compliance with regulatory requirements to maintain applicable certifications and GMP/Manufacturing Licences to support Business Strategy
* Responsible for supporting the timely registration of all current and new products with the correct regulatory authorities
* Maintain a knowledge of current and pending relevant regulations and guidance documents and communicate these to the business
* Work with the Regulatory Affairs and Product Safety Manager to identify all applicable key regulatory requirements and opportunities that relate to a product/project to support the development and ultimate successful launch of new products and into new markets


Experienced in regulatory submissions for Medical Devices or In Vitro Diagnostic Devices

Medical Devices Directive (93/42/EEC) and /or the IVD Directive (98/79/EC)

Beneficial but not essential:

Educated to Degree level

ISO13485 lead auditor and ISO14971

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