
Senior Medical Device Development Leader
4 days ago
Job Description:
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- Lead the design, development and performance evaluation of drug-device combination products to ensure they meet regulatory and quality standards.">
- Develop technical excellence, innovation and patient-centric solutions by driving technical expertise in Combination Product development.">
- Collaborate with drug product and device teams during combination product development to ensure formulation and manufacturing development activities are compatible and align with device development.">
Requirements:
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- Degree in Science/Engineering (Master's preferred).">
- 7+ years' experience in pharmaceutical and/or medical device development.">
- Working knowledge of design control requirements in line with FDA 21 CFR part 820 and ISO 13485.">
- Experience in the development and validation of analytical methods.">
- Experienced in application of statistical techniques for data analysis.">
- Experience of writing and supporting regulatory submissions.">
- Highly driven and motivated person who can work as part of a flexible, dynamic team.">
- Well-developed communication skills to lead or facilitate effective discussions.">
Benefits:
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- This role requires some travel.">
Other Information:
">A highly skilled professional is required to join our team on a permanent basis.
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