|Location: Leeds, West Yorkshire||Salary: £40000 - £50000 per annum|
|Sector: Medical Devices||Specialism:|
|Type: Permanent||Contact: Matt Henocq|
My client is a leading UK manufacturer of meedical devices for minimally invasive surgery. Alongside their own products my cleint is proud to work with other leading medical device companies on an OEM basis to design and manufacture medical devices bespoke to their clients needs.Key to the success is their team of employees. They place great value on their mutually respective relationship with employees and seek to identify, nurture and retain talent.
Overview of the role:
The focus of the role will be to work on the regulatory requirements of the business, especially by working to meet corporate objectives and contribute to growth of the business. From time to time, the role may require participation in areas of quality to ensure efficiency of business activities, continuous improvement and compliance.
Duties and responsibilities:
- Managing global product registrations projects in accordance with country-specific requirements and internal systems
- Determining regulatory pathways for product registration in various global countries
- Develop and maintain quality management systems for global product registrations
- Determine and maintain regulatory intelligence information and update quality management systems as required in accordance with this information.
- Updating relevant global, regional and local databases in the product registration process.
- Organise and maintain reporting schedules for regulatory actions i.e. licence renewals
- Participate in medical device regulatory compliance gap analyses and implementation.
- Managing and assisting with the writing and preparation of technical documentation to meet regulatory submission requirements e.g. CE submissions and US FDA 510k submissions.
- Ensuring medical device labelling compliance
- Managing the writing and reviewing of clinical evaluation reports
- Development and management of Post Market Clinical Follow Up (PMCF) projects as required.
- Distribution - Primary regulatory contact for international distributors, providing support for enquiries and requests
- Lead and manage distributor evaluation and approval
- Management of control of distributors via distributor agreements
- Effective communicator with good interpersonal skills.
- Well organised and able to manage documentation.
- Plans, schedules, and completes tasks/projects to meet deadlines and corporate objectives.
- Project management skills (work breakdown structure, basic Gantt charting, communication plan) to manage regulatory projects.
- Commercial awareness.
- Excellent communication and presentation skills.
- Adeptness in multinational regulatory strategy, collaboration with internal and external stakeholders, key opinion leaders and regulators.
- Customer focused with the ability to develop and maintain good customer relationships.
- Ability to develop and manage a high-performance team.
- Ability to lead, influence and innovate within a cross-functional environment.
- Knowledge/understanding of EU Medical Device Regulations (MDR), FDA regulations including 21 CFR 820, EU Medical Device Regulations, Canadian Medical Device Regulations and other international regulations.
- Knowledge and awareness of the requirements of ISO 13485 and ISO 9001
Services advertised by Gold Group are those of an Agency and/or an Employment Business.