Regulatory Affairs Specailist

Regulatory Affairs Specailist
  • £30,000 - £42,000 per Annum
    ANNUM
  • Permanent
  • Chester, Cheshire, England, UK Chester Cheshire UK CH5 2NU
Job Ref: J2159049
Sector: Engineering
Sub-sector: Medical Devices
Date Added: 23 March 2021
Leading global medical device organisation - opportunity for flexiable working, competitive salary, bonus.

Regulatory Affairs Specialist

  • Pre and Post Market matters within a global medical device organisation
  • Cheshire Location, with flexibility on remote working
  • Competitive Salary, Bonus, Expert Training, Flexible Work Arrangements

About the company

SRG partner with a Global Medical Technology Leader, home to a broad portfolio of critical care devices. As Regulatory Affairs Specialist, you will join a highly supportive team, approaching a period of growth within their sector.

Responsibilities

  • Ensure all regulatory compliance for medical devices products are maintained
  • Prepare and update Technical Files to MDD/MDR requirements and ensure regulatory compliance for medical devices are maintained
  • Review and load new product listings, product delisting, registration of new manufacturing sites, etc. into the registration and listing databases.
  • Maintain renewals and the up to date information for all appropriate registration and listings databases.
  • Complete inquiries and requests from internal and external sources in regard to import/export processes and practices and customs holds.
  • Maintain security for all regulatory paper and electronic files.
  • Develop, write, implement and maintain RA procedures.
  • Complete regional RA requests and provide the requested documents i.e. CFG's, LOA's, documentation, etc.
  • Review, comment and approve/disapprove change control requests which affect the marketing of medical devices.
  • Complete a Letter to File following all US FDA regulations and guidance's.
  • Review and approve/disapprove labeling change request, advertising and promotional request, field communications, etc. in accordance with standards and procedures and labeling regulations and guidance's.
  • Execute, manage and close post market activities i.e. recalls and corrections. Prepare and submit all reporting activities associated with a removal or correction with US FDA and associated OUS Competent Authorities and Regional RA team's requirements.
  • Keep informed about new and revised regulatory requirements.

Skills and Experience

  • Regulatory/Quality experience within the medical device arena
  • New Product development experience for medical devices
  • Experience of creating documentation compliant with FDA CFR 820 and EC Medical Devices Directive 93/42/EEC
  • Experience with US 510K would be preferable

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.

SRGTalent
22/04/2021 13:48:06
GBP 30000 42000 Annum
Contact Consultant:
Holly Evans

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