Job Opportunity:
We are seeking a highly skilled professional to lead the development of drug-device combination products.
This is a senior position that requires expertise in technical excellence, innovation, and patient-centric solutions, ensuring regulatory and quality standards are met.
* Provide subject matter expertise for Combination Product development
* Plan and execute design verification and reliability strategies
* Develop design requirements and specifications based on characterization of comparator products, regulatory requirements, and user requirements
* Use statistical techniques and data analysis to inform design decision making
* Ensure all activities within the team are conducted to appropriate quality standards
Requirements
* Master's degree in Science/Engineering
* 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 would be an advantage
* 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 individual who can work as part of a flexible, dynamic team
Why Choose This Role?
* Opportunity to lead the development of innovative drug-device combination products
* Collaborative and dynamic work environment
* Chance to apply your expertise and make a significant impact
What We Offer:
* Competitive compensation package
* Comprehensive benefits program
* Ongoing training and development opportunities
How to Apply:
* Send your resume and cover letter to us
* Discuss your qualifications and interests with our team