Description
The job is a Senior Regulatory Affairs Officer's role within a team of regulatory personnel, reporting to a Manager working on a variety of regulatory projects. Work carried out by project teams, as directed by Regulatory Affairs personnel can have a significant impact on timing and costings of new product launches. The accuracy of the advice given can have an impact on the success of the project.Reliance is placed on personnel to maintain existing registrations in line with current regulations. A failure to ensure that this happens may place the company in danger of loss of registration and sales in that region.
Key accountabilities;
- To compile, review and approve, as required, regulatory despatches in accordance with national requirements to ensure appropriateness and consistency in consistency in content and presentation of information both within and between registration applications.
- To deputise for the NPD Regulatory Lead, where appropriate and when required.
- To complete the requirements of the Registration Programme as agreed with the AWM GBU and Operations departments.
- To provide on-going regulatory advice to project teams throughout product and process development to ensure regulatory concerns are planned and accounted for and the relevant data generated to meet project objectives.
- In relation to the above, to interpret individual country legislation relevant to the S&N AWM business.
- To provide advice and guidance, in an expert capacity, to the AWM GBU RA staff.
- To liaise with external regulatory authorities to ensure approvals are obtained in line with the launch plan.
- To review and approve artwork, labelling and promotional literature and advise on its acceptability/compliance with regulations and registered details.
- To review and approve change control impact assessments for products.
- To approve European Technical Files and regulatory despatches, where appropriate.
- To perform all activities in compliance with relevant GMP and Quality Systems standards and specifically with FDA Quality System Regulation and ISO 13485.
Required Experience;
- An honours degree, in a science, engineering or electrical engineering subject
- Substantial knowledge and experience of the medical device industry and the relevant regulatory bodies (ideally on a global basis and in the electro medical device arena)
- A minimum of 3 years directly relevant regulatory experience
- Strong project management skills, with proven experience of planning and prioritising
- Good interpersonal skills and the ability to influence both internal customers and external regulators
The Client is looking to pay from 35-45k and has a good relocation package, as well as healthy Benefits package. If you would like to hear more, then forward me your CV and I will be in touch shortly.
To find out more about Real please visit www.realstaffing.com