Job Purpose and Primary Objective
- The Clinical Leader is responsible for management and execution of all clinical research requirements covering the full product life cycle of the company product range, which covers innovative design of diabetes insulin cartridge, pump device with BGM (Blood Glucose Monitoring) and control handset. (Class IIb and Class III)
- The role requires a professional, proficient and organised approach dealing with key customers and notified body groups to strengthen relationships and assess market entry with clinical requirements.
- To support the overall clinical affairs strategy in Europe, with specific attention to France and UK, to oversee initiation, progress and conduct of European clinical studies, physician initiated research activities and publication efforts, to define the CE marking and reimbursement strategies of innovative products (apps, algorithms, …).
- The candidate will ensure compliance with all local regulations, Good Clinical Practices (GCP), ISO14155.
- Ability to speak both fluent French and English required to support.
Roles and Responsibilities
- Coordinate communication plans to Key contacts in-line with corporate strategic goals
- Develop clinical evidence strategy to address regulatory and reimbursement gaps, or otherwise for the medical community as required
- Actively represent clinical affairs in France and UK for reimbursement or other government agency meetings or conferences as required
- Lead the organisation with respect to Clinical oversight of changes in regulations and structured planning of implementation to the business covering MEDDEV 2.7.1 Rev 4 introduction
- Management and engagement of Clinical Research reviews
- Management of multi country clinical requirements to support CE marking and FDA approval
- Engage and implement the MDR changes and PMCF (post market clinical follow up) practices within the QMS
- Define the most efficient strategies to CE marked innovative products mobile apps, algorithms…, prepare and submit files
- Coordination of full product life cycle clinical requirements, covering:
- Design and Development clinical risk evaluations to support FMEA’s
- Clinical Studies support
- CER’s – Clinical Evaluation Reporting
- Clinical Benefit and Safety
- Clinical Vigilance and PMS – Post Market Surveillance
- Hold strong relationship management with key contacts and liaison with regulated bodies (e.g. LRQA, FDA,GMED,ANSM) to support clinical requirements and strategies for new product implementation
- Management of strategic mapping to cover the product business plan
- Support in logistics and administration coverage of reimbursements and Develop necessary documentation and files to get the best possible reimbursement
- Undertake any other specific tasks as detailed by the VP QA/RA, CEO and Executive Team direction
- Ensure own compliance with health and safety regulations
- Ensure compliance with QMS and Medical Device Regulations covering IVD and MEDDEV
- Degree level candidate or equivalent experience
- Demonstrated Clinical background and diversity of the Clinical requirements covering Medical Devices
- Ability to speak both fluent French and English
- Excellent IT, literacy and numeracy skills.
- Excellent oral, written, cross functional and interpersonal communication skills that are appropriate for various levels, including management, staff, contractors and clients
- Good team-working skills including commitment and flexibility
- Analytical and problem solving approach
- Effective organisational and decisions making skills
- Demonstrates a positive attitude to change and contributes to new ideas and improved ways of working.
- Demonstrate sound work ethics.
- Works well with colleagues inside and outside the team. Looks beyond boundaries of own job to support others.
- Clinical Experience of working in the Medical Device / Manufacturing sector
- IVD product coverage advantageous.
- Knowledge of clinical entry to market for new/ innovative products support