Senior Regulatory Affairs Specialist, EMEA

Insulet Corporation ,
London, Greater London
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Job Description

The Senior Regulatory Affairs Specialist will play a critical role and leading role in administering global regulatory registration activities by preparing international regulatory submissions and tracking registration activities prior to, and following completions of, registration approvals for applicable products. The role will also include working independently with Marketing, Product Development, Consultants and Dealers to compile, consolidate and deliver information and documentation required for regulatory filings in numerous countries within global identified markets. The role will also support plans to achieve identified corporate regulatory objectives identified and contribute to the development of regulatory strategies and tactics to achieve business or objectives which are subject to regulatory authority oversight. The Senior Regulatory Affairs Specialist will also be responsible for keeping abreast of and providing regular reporting to regulatory leadership on key regulatory developments that impact customers or business directly. + Understand applicable regulations covering the life cycle of a medical device, including country specific requirements, and regulatory requirements for new products or product enhancements during the product development cycle. + Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support product claims. + Work with senior Regulatory Affairs personnel to advise project teams of applicable regulations, country specific requirements, and requirements specific to the product (eg. labelling). + Assist in evaluating changes to current products, systems and processes, based on regulations. + Keep abreast of existing and new regulatory requirements, including national and regional requirements (eg. EU, Middle East, APAC). + Review & approve written & imagery materials for compliance and consistency for labelling and promotional content. + Support Regulatory Affairs compliance activities as necessary in assigned regions. + Bachelor's degree in Life Science + 3-6 years' experience in Regulatory Affairs in Medical Device. + 2-3 years Regulatory Registration experience + Good understanding of medical device industry such as EU Medical Device Directive, EU Medical Device Regulations. + Working experience in business matrix environment and providing quick, salient analysis and corresponding action plans based upon understanding. + Good current knowledge and competence in interpretation of requirements for meeting regulatory conditions for medical devices around the world. Skills/Competencies: + Comprehension of government and industrial developments and changes in the regulatory environment. + Able to anticipate business needs and interests and support the development of proactive approaches/responses. + Proactive, excellent capability to engage and interact, effectively and credibly, with internal and external business and regulatory stakeholders + Excellent communication organizational and interpersonal skills + Fluent in English, a second European language is a plus Location: + This role will be based in the Insulet International Head Office in London. External Company Name: Insulet Corporation External Company URL: Street: 21 Holborn Viaduct

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