Regulatory Affairs Officer
Reporting to the Regulatory Affairs Manager, the successful candidate will be directly involved in the management of regulatory projects which will include product life cycle, new product development and regulatory processes. Development in premarket submissions/ design reports for products which are intended overseas will also be involved.
Key duties and responsibilities include:
*Preparation, submission and facilitation of medical devise regulations (Class II 510(k) in accordance with the FDSA's Code of Federal Regulations, Title 21.
*Preparation, submission and facilitation of medical device regulations (Class II and Class III) in accordance with the Canadian Medical Device Regulation SOR-98-282.
*Maintain each cleared medical devise regulation filings following changes to product, processes and labelling.
*Maintain each cleared Medical Device Licence (MDL) following changes to product, process or labelling.
*Directly liaise with international regulatory agencies and provide supporting documentation, address any queries and issues
*Provide general advice on regulatory strategy for new product developments, product re-development and process changes
*Add guidance to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality
*Offer assistance and support with the regulatory compliance of marketing communications/messages products and services.
*Monitor and keep abreast of changes in legislation, standards and guidance documents.
*Contribute to the development and implementation of regulatory policies, procedures and specifications across the company and ensuring that these are compliant with the Quality Management System.
*Plan own workload, influence personal training and assisting in setting appropriate time lines for projects.
*Adhere and encourage Company, HS&E and Quality procedures and standards to enable the site to achieve and maintain excellent results.
To be considered for this role, candidates must have an understanding of medical device standards and regulations and how they apply. Be able to absorb information quickly and be an effective communicator across countries and cultures. You will be educated ideally to degree level in a scientific, medical or engineering background and possess at least 4 years Regulatory Affairs experience. Previous experience of submitting 510(k) submissions to the FDA required as well as Class II and Class III Medical Device Licence applications to Health Canada. (Advantageous)
You will also be experienced in operating in an ISO 13485 and 21 CFR.820 certified Quality Management Systems.
FDA 21 CFR 820, specifically Parts 807 and 814.
Canadian Medical Devices Regulation SOR/98-282.
ISO 13485 and 21 CFR 820 Quality Management Systems
ISO 14971 Risk Management of Medical Devices.
In return you will receive a competitive salary and excellent benefits. 38.4 hours a week working (Flexible hours) and the opportunity to be a part of an organisation who are involved in ground breaking research and medical device manufacturing.
Acorn Recruitment acts as an employment agency for permanent recruitment.
- 'Regulatory Affairs'
- 'Medical Devices'
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