Reg Affairs Specialist
- Experience Level
- Experienced (non-manager)
Regulatory Affairs Specialist
On behalf of my client, I am recruiting for a Regulatory Affairs Specialist.
The successful candidate will report to the RA Supervisor and will be responsible in ensuring continuous compliance with regulatory standards. This person will be working closely with Quality, Operations and Sales and Marketing.
This is a 12 month contract position.
- To ensure the company’s continuous compliance with the following regulatory standards:
- The FDA Quality System Regulation 21 CFR 820 (QSR)
- The In Vitro Diagnostic Medical Devices Directive 98/79/EC
- In-Vitro Diagnostic Devices (IVDR) Regulation 2017/746
- Health Canada Medical Devices Regulations
- ISO 13485 Quality Management Systems Requirements for Medical Devices
- Provide Regulatory advice & support to the company business units.
- Liaise with all Professional & Regulatory bodies in the industry on regulatory or legislative changes, and ensure effective implementation.
- Manage and co-ordinate all company vigilance/recalls activities.
- Provide guidance on worldwide regulatory requirements, providing regulatory strategies and co-ordinating during transfers, registrations.
- Work as part of project teams in support of product registrations and liaison with customers and regulatory bodies during this process.
- Create and maintain product technical files according to the IVD Directive 98/79/EC
- Act as Regulatory Affairs representative on the Design Control/Change Committee.
- Responsible for maintaining awareness of the changing regulatory requirements.
- Represent Regulatory Affairs at regulatory and customer audits.
- Completing LCO activities as required by the printed material change control (PMCC) system including:
- Review of printed material against applicable guidance (i.e. FDA, EU, Canadian, WHO and ISO guidelines)
- Review and approval of a printed material changes, where applicable
- Proof reading of printed material against requested change
- Setting up of approved overprinted label templates
- Liaise with approved vendors for translation activities
- Preferably 3 years’ experience in a regulatory affairs role in the Medical Device/IVD industry.
- Experience in IVDR and labelling is advantageous.
- Understanding of current Regulatory standards.
- Third level qualification in a science or related discipline or equivalent in terms of relevant operational experience.
- Excellent organisational, planning and judgemental skills with excellent attention to detail.
- Excellent analytical/decision making skills, and ability to work independently.
- Ability to identify and drive regulatory compliance improvements.
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