Drug-Device Combination Product Consultant

Black Swans Exist
Position Overview:
We are seeking a highly skilled and motivated Drug-Device Combination Product Consultant. The consultant will play a pivotal role in the design, development, and optimization of novel drug-device combination products, ensuring they meet regulatory standards and effectively address women’s reproductive health challenges.
Key Responsibilities:
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Product Development: Lead the design and development of drug-device combination products, focusing on integrating microbial immunotherapies with appropriate delivery systems.
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Regulatory Compliance: Ensure all combination products comply with relevant regulatory requirements, including ISO 13485, ISO 14971, and applicable FDA and EMA guidelines.
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Quality Assurance: Develop and implement quality management systems specific to combination products, overseeing risk management, design control, and CAPA management.
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Cross-Functional Collaboration: Work closely with R&D, clinical, and manufacturing teams to ensure seamless integration of drug and device components, facilitating successful product development and commercialization.
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Technical Documentation: Prepare and review comprehensive technical documentation, including design history files, technical files, and regulatory submissions.
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Project Management: Manage timelines, resources, and budgets effectively to ensure project milestones are met.
Qualifications:
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Advanced degree in Biomedical Engineering, Pharmaceutical Sciences, or a related field.
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Minimum of 10-15 years of experience in drug-device combination product development within the pharmaceutical or biotech industry.
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Proven expertise in regulatory submissions and compliance for combination products.
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Strong understanding of quality systems and risk management principles.
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Excellent project management and communication skills.
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Ability to work collaboratively in a fast-paced, innovative environment.
If you are passionate about advancing women’s reproductive health and have the expertise to drive the development of innovative drug-device combination products, we encourage you to apply.

Per Christensen
Managing Director & Co-founder
Per is the Managing Director and Co-founder of Black Swans Exist, a role he has held since the company's inception in June 2020. Based in Copenhagen, Per brings a visionary approach to the business, helping companies discover rare, high-impact talent, or "Black Swans," that drive extraordinary performance.
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