As a Regulatory Affairs Specialist you will be responsible for Regulatory Affairs support of the product development process, submissions and regulatory compliance.
Role: Regulatory Affairs Specialist
Contract: initial 12 months
- Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
- Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
- Act as a team member in product development programmes and demonstrates a good understanding of the PDP process.
- Maintains and enhances cross-functional team relationships.
- Review applicable Corporate SOP's for effect on local regulatory processes and systems.
- Prepare and maintain Technical Files and Design Dossiers.
- Prepare and maintain FDA submissions including IDEs, 510k's and PMAs.
- Review and approve documentation related to product release.
- Provide input, review and approve artwork for labelling and DFU's
- Participate in Regulatory body audits, such as FDA, Notified Bodies, Compentent Authorities and other global regulatory agencies.
- Liaise and provide support to international regulatory colleagues.
- Demonstrate and actively promote highest level of professional regulatory discipline.
- Liaises with both middle and senior management on any regulatory issues relating to their area.
This is an excellent opportunity to work within one of the world's leading medical device companies and work on devices that really changes people's lives.
No CV ready? Want to know more? Feel free to get in touch about further details!
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales