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Regulatory Affairs/Quality Assurance Consultant - Medical Devices
* Regulatory/Quality Expertise in Medical Devices and IVD's* Ability to travel nationally on occasion.* Competitive Salary
SRG are currently recruiting for a Regulatory Affairs Consultant to join a leading Life Science consultancy firm. Your expertise in the medical device industry will enable you to advise clients on how to best meet the regulatory requirements of MHRA, FDA, Notified Bodies and ICH.
Provide informed regulatory support to a portfolio of clients assisting with the development, approval, manufacture, storage and distribution of their products.
* Develop and maintain relationships with external stakeholders - working within external technical, quality and regulatory teams to provide consultancy services* Advise on policy objectives such as government organisations, regulators and other trade associations* Provide specialist direction on QMS Design, Implementation, Maintenance, Risk Management* Set up of Technical Documentation and Design Dossiers in support of the CE marking process and other International Regulatory compliance processes, including clinical requirements.* Regulatory strategy - ability to advise on straightforward and successful routes to both pre and post market* Interim management support/training* Internal and external auditing Skills and Experience * BSc, MSc of PhD degree in Life Sciences or similar field* Significant Regulatory and Quality experience within the medical device arena* Post Market Surveillance and Vigilance Requirements for Medical Devices/IVD's* Internal or Lead Auditor to ISO 13485* Experience with Risk Management to ISO 14971* Autonomous, self-motivated professional who works well under pressure
Please contact me: Holly.Evans@srgtalent.com or +447909 207 693 for a confidential discussion around your career in Regulatory Affairs/Quality Assurance within the Med Tech arena.