Regulatory Affairs Specialist - West Sussex £40,000 - £45,000
Are you an experienced regulatory affair professional within medical devices?
Have you knowledge of ISO 13485 and the MDD/MDR?
This is an excellent opportunity to join a leading medical device company who are leaders within their field.
Roles and responsibilities:
The Regulatory Affairs Specialist will have the following duties:
- Developing registration and launch plans with the regional sales managers to ensure that
- The preparation and submission of registration dossiers, and their submission and
- Establish and maintain regulatory information systems such as technical documentation, quality records, routine reports and regulatory agency communications
- Ensure compliance to global regulatory requirements and company policies
- Review document and product changes for regulatory submission impact
- Interface and co-ordinate with regulatory agencies; provide regulatory input and appropriate follow-up support to inspections and audits (e.g. FDA, Notified Bodies etc)
As Regulatory Affairs Specialist, you will ideally have the following skills, experience and knowledge:
- 2-3 years' experience in a regulatory role within medical devices
- A degree or formal qualification within a scientific or suitable subject
- Experience with ISO 13485 and CFR
- Knowledge of registrations for the following countries would be desirable - India, China, Russia, Brazil and USA
The successful candidate for the role of Regulatory Affairs Specialist will receive the following:
- Salary - £40,000 - £45,000 (could be negotiable for someone with exceptional experience)
- Company pension
- Excellent working environment and career prospects
This role is commutable from Crawley, Brighton, Worthing, Chichester, Horsham
Keywords: Regulatory affairs, RA Specialist, RA Analyst, Regulatory affairs analyst
- medical devices
- regulatory affairs
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