Closing Date: 19 Dec 16
Salary (£): Negotiable
I am currently working on behalf of my client, a leading Medical Device company, to fill the position of Regulatory & Risk Manager. The key objective of this role is to develop a regulatory strategy to support all target markets, and to maintain regulatory compliance as required.
Your key responsibilities will include, but not be limited to
* To drive the company to deliver sufficient depth of evidence to demonstrate regulatory compliance.
* To drive the vigilance processes required in Europe, US and other relevant markets.
* To deliver PMS report, Vigilance Report and clinical evaluation report in line with the relevant plans.
* To define the appropriate regulatory pathways for entry into global markets and support other members of the company in understanding the regulatory pathways.
* To provide advice on possible approaches to de-risking and accelerating project completion.
* To provide advice on approaches taken by other companies for comparable products in satisfying regulatory requirements.
* To provide risk assurance support into the design and development process, to assure risk consideration and acceptability as ALAP throughout the product development lifecycle.
* To provide managerial leadership for RA team members, ensuring that there is a common agreement on strategy, priorities and deadlines, and to maintain a strong understanding of delivery against plans and targets.
* Strong understanding of regulatory standards and their implementation in a Medical Device framework i.e. Medical Device Directive (93/42EEC), ISO 13485, ISO 14971, IEC 60601,IEC 62366, IEC 62304, 21 CFR 820,21CFR 807, 21 CFR 11.
* Experience in working with PEMS (Programmable Electrical Medical Systems) or equivalent high-integrity software-intensive systems i.e. complex devices requiring multidisciplinary development effort (mechanical engineering, software, electronics, system integration, pneumatics, fluid mechanics, etc.).
* Experience of working with risk management, regulatory requirements, document management systems, issue management systems.
* Trained in application of IS014971.
* Ability to work with external bodies.
* Extensive experience working in product development & delivery.
* Sound technical knowledge of product base and application.
* Degree or equivalent experience in appropriate subjects.
For a confidential discussion about this role please call Rachel on +44(0)2033273072 or send your CV to email@example.com
4th Floor, 150 Leadenhall Street, London
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