Regulatory Affairs Specialist (MDD)
Summary: Working for a Global Medical Devices Manufacturer, you will handle EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities).
Description: Regulatory Affairs Specialist
Salary is negotiable on experience
Working for a Global Medical Devices Manufacturer, you will handle EU product submissions, license renewals, and periodic updates and registrations to regulatory agencies (FDA and EU regulatory entities).
The Main responsibilities of this role are: -
*Ensure all regulatory requirements are met throughout the development process
*Updates and maintain Design History Files and associated documents
*Completes submissions to EU and FDA regulatory entities as needed
*Create and maintain product EU Technical Files
*Collect and coordinate information and the preparation of regulatory documentation for submissions to regulatory agencies and advise on the submission strategy
*Maintain regulatory files
*Establish and maintain a tracking system for changes in documents submitted to agencies and/or customers
*Support the site in the timely renewal of certificates, licenses, and registrations
*Auditing and ensuring the standardization of all Product Technical Files
*Assist in the creation and approval of product labelling, TDS, MSDS, and instructions for use
*Review and provide regulatory oversight for marketing literature for compliance with the relevant regulatory requirements
*Provide the regulatory review of customer complaints
*Utilize your regulatory knowledge and expertise, provide support and expansion of the Regulatory Services function as part of the Product Life Cycle Management (PLM) process to customers
*Maintain your current knowledge of MDD, FDA and international regulations
*Participate in research of regulatory issues and dissemination of regulatory information to Production, QA, QC, R&D department, and Senior Quality Management
*Execute compliance GAP audits with remediation plans at sites
*Support the acquisition of monthly regulatory quality metrics and KPIs.
*Monitor CAPA activities for key accounts internally and externally escalate process failures to the Senior Management team
Essential background: -
*Have a minimum of 5 years relevant experience within the regulatory affairs discipline, including Medical Device, Biotechnology, and/or Pharmaceutical experience
*Have a strong regulatory affairs knowledge and experience with quality systems regulations and guidelines, ISO 13485, ISO 14971, GMP (21 CFR 820), Medical Device Directive (MDD), Canadian Medical Device Regulations (CMDR), Therapeutic Goods Administration, Australia (TGA) and US FDA regulatory requirements
*Represents Regulatory Affairs on product life cycle management project teams to ensure all regulatory requirements are met throughout the whole of the development process
*Enforce a compliance culture towards the QMS and Regulatory requirements
*Complete submissions to FDA and EU regulatory entities
*Provide regulatory knowledge expertise to ensure compliance to all regulatory requirements and laws
*Knowledge of all corporate requirements, global Regulatory and Quality requirements for the manufacturing and marketing of medical devices
*Have knowledge of a QMS and various manufacturing processes in either medical device of pharmaceutical development
*Demonstrate experience of interfacing with FDA/Regulatory inspectors and customers during customer audits
*Have strong Project Management, technical, analytical & problem solving skills
*Excellent verbal, written and presentation skills so you can communicate and influence at all levels
*Solicit feedback and information from others
*Experience with Class II devices mandatory, Class III desirable
Desirable experience includes: -
*Good Laboratory Practices (21 CFR Part 58)
*Bioburden, Biocompatibility, and Microbiological Testing
*Be a Lead Auditor for ISO 13485
*FDA 510K Submissions
For more information and to apply for this position, please send your CV with a covering email to explain why you feel you should be considered for this post.
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iNTECH Recruitment Ltd are experts in the recruitment of technical staff within the Manufacturing and Engineering industry, this includes electronic, electrical and mechanical engineering disciplines. We act as both an employment agency for all permanent positions and as an employment business for temporary contract positions.
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Regulatory Affairs Specialist (MDD)