MDR Senior Regulatory Executive - Hertfordshire
CK Group is recruiting for a Medical Device Regulation Senior Regulatory Executive to join a company in the pharmaceutical industry at their site based in Ware on a contract basis for 12 months.
The Company: Our client is a global healthcare company who take on some of the world's biggest healthcare challenges. They provide health benefits to patients and consumers and have three world-leading businesses that research, develop and manufacture innovative pharmaceutical medicines, vaccines and consumer healthcare products.
The Location: This role is located on a state of the art R&D facility based in Ware, Hertfordshire. The town lies on the north-south A10 road which is partly shared with the east-west A414 (for Hertford to the west and Harlow to the east). Trains run from London Liverpool Street to Ware and take approximately 45 minutes.
The Role: Our client has a range of medical devices and combination products which are impacted by the MDR and is establishing both an implementation and lifecycle team to address the new requirements.
Work will include, but may not be limited to:
- 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 company personnel to ensure accuracy of such records. Work to agreed deadlines, with ability to respond readily to changing events and priorities.
Tasks will include, but may not be limited to:
- Drafting CER documentation.
- Reviewing clinical trial material to understand if the MDR requirements are met.
- Assist in compiling Annex I and II checklists for devices.
- 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.
Your Background: The role requires the following skills:
- 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 Documentum systems.
- Demonstrated problem solving skills.
- Degree in Engineering, Pharmacy, Chemistry or related discipline.
For more information or to apply for this position, please contact Jenni on 01438 768710 or email email@example.com. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45867 in all correspondence.