Senior Regulatory Affairs Specialist

Salary: £75,600 – £97,200 per year

Company
Our client is a medical devices producer, a wholly independent company with its headquarters in Hong Kong and manufacturing operations in China. It has a distribution network which stretches globally with a name built on quality, trust, and integrity.
Role summary
The Senior Regulatory Affairs Specialist will help developing strategies to ensure regulation compliance. He will make sure that the necessary documentation is completed and submitted. He will keep each department informed of applicable regulations and what needs to be done to ensure the regulations are fully and properly followed.
Responsibilities
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Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations and initiate any relevant regulatory submissions as a result of the outcome.
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Supports Sustaining Projects such as design changes, material changes, supplier changes etc and works as part of a core team with other functions to execute these changes.
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Provides guidance to management on upcoming regulatory changes (Brexit, MDR) and the impact of those changes.
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Responsible for product registration and manage government approval in a timely manner
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Establish and maintain a close relationship with government agencies to achieve operational effectiveness
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Support the marketing department to develop strategic method for product launch in the EU and Northern America.
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Prepare regulatory documents and assist the sales team on tender and quotation submission
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Support QA, Engineering, Marketing teams in both Ireland and GA Hong Kong for Field Corrective Action and determine the following activities such as government reporting and recall.
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Support the communication of Recall / Field Action activities between manufacturers and distributors in Europe and North America.
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Input and adherence to the scheduling and management of Post Market Surveillance (PMS) plans and reports, Post Market Clinical Follow Up (PMCF) plans and reports, and clinical evaluations (CEPs, CERs). Maintains appropriate regulatory records to demonstrate compliance with applicable regulations.
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Proactively create regulatory training with the HR to the internal parties.
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Liaise and provide support to Marketing and the Engineering team in the International emerging markets.
Requirements
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Level 8 Degree (BS, BA) (Technical discipline preferred).
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5-7 years’+ Regulatory experience. Experience in the medical devices area.
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Have a good understanding of the Regulations in the various jurisdictions. EU, US, China, Japan, Australia, Canada etc.
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Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
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Ability to work effectively within a team in a fast-paced changing environment.
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Strong verbal and written communications with the ability to effectively communicate at multiple levels in the organization.
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Ability to travel approximately 10%, including international.
Attractive remuneration will be offered in line with experience and would be firmed up during the interview process. If interested to explore please apply enclosing your CV in Word format and Cover Letter.