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Research and Development Manager
2 months ago
Job Summary:
We are seeking an experienced Research and Development Manager to join our team at Advanced Medical Solutions. As a key member of our R&D team, you will be responsible for managing and developing our medical device products.
About the Role:
- Manage and motivate a team of scientists and technicians to develop and design medical devices that meet business needs and regulatory requirements.
- Oversee the R&D budget and ensure that projects are completed on time and within budget.
- Support the design and development of products through analytical and performance testing, ensuring that they meet business needs and regulatory requirements.
- Ensure that the R&D team has clear objectives to meet company needs and that they are maintained in compliance with regulatory requirements.
- Maintain ongoing compliance of R&D personnel, facilities, and activities with applicable regulatory requirements, standards, and company policies/procedures.
- Ensure that R&D personnel maintain safety practices and GMP/GLP in company facilities.
- Ensure that all devices developed have a maintained design history file and risk management file.
- Originate R&D documentation such as protocols and reports.
- Review and approve documents generated by the R&D team, when necessary.
- Generate monthly reports on project, resource, and budget updates.
- Keep all stakeholders informed of R&D progress and issues.
- Ensure that the R&D team provides appropriate support to other department objectives, including technology SME, stability, corrective and preventive actions, and audits.
- Analyse, mitigate, and monitor project risks and establish contingency plans and identify trigger events and responsibilities for initiating corrective action.
- Represent R&D interests at a senior level and be involved in strategic activities throughout the wider organisation.
Requirements:
- Educated to degree level in a scientific discipline.
- 5+ years of experience in R&D, with at least 2 years in a managerial role.
- Proven record in test method development and validation.
- Ability to think innovatively to identify solutions.
- Experience of managing an R&D team of scientists.
- Demonstrates ability to apply regulations without guidance.
- Able to work collaboratively and effectively in multidisciplinary teams.
- Driven to achieve results.
- Good time management and organisational skills.
