Senior Regulatory Affairs Executive – Medical Device
My client, a global pharmaceutical development company whose product portfolio includes a range of medical device and combination products which are impacted by the MDR. They are establishing both an implementation and lifecycle team to address the new requirements, and are seeking a temporary worker to work within the team in implementing the requirements of the MDR.
Senior Regulatory Affairs Executive Responsibilities:
Preparation of high-quality Clinical Evaluation Reports (CER) and technical files for Medical Devices (including those related to combination products), using varied information sources and liaising closely with other personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
- Drafting CER documentation
- Reviewing clinical trial material to understand if the MDR requirements are met
- Assist in compiling Annex I and II checklists for device
- Assist in regulatory strategy planning for technical file submission
- Assist in risk assessment process
- Update SOPs and/or create new SOPs to detail ways or working
- Engagement with Notified Body organisations
- Experienced in Medical Device regulatory affairs – including responsibility of non-clinical and clinical requirements.
- Good written and oral communication. Demonstrated ability to focus, work with attention to detail and retain critical information.
- Demonstrated team working skills, with the ability to establish strong relationships and liaise effectively with sites worldwide.
- Demonstrated effective time management skills.
- Be proficient in the use of IT packages such as Word, Excel and Document systems.
- Demonstrated problem solving skills.
- Degree in Engineering, Pharmacy, Chemistry or related discipline
Senior Regulatory Affairs Executive Desired Experience
- Global experience, (with a specific focus on EU requirements), in Medical Devices and CER for Medical Devices. Working knowledge of MDR implementation with a focus on clinical requirements.
- Prior experience in MDD technical dossier submission, Notified Body interactions and preparing technical files for Medical Devices (including CER) and managing the related responses to questions. Lifecycle management of Medical Devices / Combination products.