Description
My client is now looking to expand their products globally in to new markets as well as continually developing new and existing products. Because of this there is now a demand for a Regulatory Affairs Officer.Main Responsibilities;
- Develop and maintain Essential Requirements/Principles checklists.
- Maintain the compliance library and the list of applied standards. Review the impact of changes to standards and help manage any required conformance and engineering change activities.
- Write and maintain (update and review annually) risk assessments specifically and the risk management file and support the overall risk management activity across the product lifecycle (e.g. to ISO14971).
- Write and submit product submissions to relevant regulatory agencies (CE Notified Body, FDA, Health Canada etc.).
- Manage global product listings and registrations.
- Record complaints and manage their response and closure. To support with vigilance reporting, field corrections and recalls.
- Provide input to the ongoing management of the CAPA system (complaints, returns, non-conformances, deviations, corrective actions).
- Manage post market surveillance activities including reviewing data on RDT's devices, competitor's device and changes in regulator's requirements/interpretations/posture.
- Manage collection and presentation of clinical data and perform documented reviews of it post-market.
Essential Requirements;
- Experience working within the medical device industry in a regulatory role for a class II active medical device manufacturer is a requirement.
- Evidence of training in medical device regulatory affairs is required.
- Knowledge and experience of working within the following:
- ISO 9000, ISO13485, ISO14971, CMDCAS and FDA good manufacturing practice regulations (21 CFR Part 820).
- Product submissions (e.g. 510k, CE marking), product certification, technical files, FMEA, clinical data files, product recalls/corrections, post-market surveillance
Preferred experience;
- IECnd or 3rd edition), EMC testing, environmental testing (e.g. MIL810, IEC60068), IEC62304
- Experience of working directly with regulators is desirable but not a requirement.
- Experience of FDA PMA process and class III products is desirable
- Experience with International markets is desirable
This role is paying from £40-£55,000 so if you feel you have the correct experience and want to hear more please send me your CV and I will be in touch shortly.