Senior Device Development Specialist
11 hours ago
We are seeking an experienced Senior Device Development Specialist to lead project teams in their awareness of current regulatory best practice when building device development plans.
The successful candidate will have advanced knowledge of global Medical Device and Drug-Device Combination Product regulatory requirements, including 21 CFR 820 and MDR (EU) 2017/745. They will also have experience in multi-disciplinary teams within a pharmaceutical development environment, with a significant proportion having a drug delivery/device focus.
The role involves providing expert advice to the EU regulatory function in relation to the device constituent of Drug Device Combination products, and collaborating within program teams to ensure regulatory strategies are disseminated and understood.
- Maintaining detailed awareness and understanding of current regulations and regulatory guidance in regions of interest to our development programs.
- Leading project teams in their awareness of current regulatory best practice when building device development plans.
- Providing mentoring for, and support the development of, the Technical Regulatory team.
- Collaborating within program teams to ensure regulatory strategies are disseminated and understood.
- Driving the authoring and review of documents for regulatory submissions.
Key Responsibilities:
Our ideal candidate will possess excellent communication and interpersonal skills, with the ability to work effectively in a fast-paced environment. We offer opportunities for career progression and professional development.
What We Offer:
A competitive salary and benefits package, as well as opportunities for career progression and professional development.
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