Regulatory Affairs Specialist

Job Ref: J26364
Sector: Science
Sub-sector: Medical Devices
Job Type: Permanent
Date Added: 24 April 2018
  • Chester, Cheshire, England, UK
  • £30,000 - £40,000 per Annum
  • Laith Mustafa
  • 0161 868 2231

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Job title: Regulatory Affairs Specialist Location: North WestCompany overview: This is a global medical device company, employing over 8500 people, operating in 100 counties, with an annual revenue of $1700 million. Brief role summary:The individual who takes this role on will be the regulatory advisor for the company. They will be responsible for ensuring regulatory compliance for their products globally, which will include preparing the correct documentation for the countries in which they operate as well as overseeing regulatory processes throughout the product life cycle. Responsibilities: * Creation and maintenance of regulatory documents * Prepare pre-marketing documentation, via liaising with the R&D, operations and others to ensure the RA pathway has been carved within the full project plan. * Build relationships and negotiate with regulatory bodies when required Minimum Qualifications/Experience:* Life science degree or equivalent * Regulatory/Quality experience in medical devices. * Experience dealing directly with authorities, such as the FDA. * Hands on experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC and knowledge of the key international standards such as ISO 13485 and ISO 14971* Demonstrate excellent communication skills with people from a variety of professional backgrounds. * Demonstrate the ability to be flexible, open minded, and be able to adapt to a rapidly changing environment.Additional information:10% travel, possibly globalFor more information please contact Molly Cooley on 07495483519 /

The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.

SRG
24/05/2018 13:45:48
GBP 30000 30000.