Regulatory Affairs Manager - Combination Products - Ventura Solutions LLC

Are you a skilled product development or quality engineer with experience in combination products, looking to grow in a manager position in Chicago? We are recruiting for this direct placement opportunity with one of our clients. 

Our client is seeking an individual who is eager to expand their skill set and grow within the role, demonstrating a keen interest in learning the process and operations.  The ideal candidate will have a strong background in combination products, engineering, management, and a proven track record of success managing complex projects.  

Responsibilities

• Manage a team of engineers.
• Oversee the creation and maintenance of Design History Files (DHF) in accordance with regulatory requirements.
• Develop and implement risk management strategies for combination products, ensuring the safety and efficacy of the final product.
• Perform Combination Product development activities in compliance with 21 CFR 210, 211, and 820.
• Lead design control activities in accordance with ISO 13485 and FDA 21 CFR 820.30.
• Lead risk management and risk analysis activities in accordance with ISO 14971.
• Lead Quality and Regulatory Services Initiatives: Manage aspects of combination product programs and projects, coordinating with both internal teams and external clients to achieve defined outcomes.
• Collaborate Across Functions: Partner with teams in Sales, Marketing, R&D, Human Factors, Risk Management, Quality, and Regulatory to integrate customer requirements and streamline development and submission processes.
• Support and Knowledge Sharing: Mobilize support from internal experts to enhance project management, quality, and regulatory. Ensure comprehensive service offerings to pharmaceutical partners.
• Align Objectives: Ensure customer needs are met in alignment with our client's strategic objectives, maintaining active involvement of internal stakeholders.
• Provide Expert Guidance: Educate and guide customers on drug delivery systems, quality, and regulatory requirements.
• Enhance Industry Understanding: Keep abreast of industry developments and combination products through regular participation in conferences and trade shows.
• Maintain Compliance Documentation:
• Ability to author, review, and approve clear and concise quality and regulatory documents
• Oversee regulatory documentation related to combination products to ensure compliance.
• Effective Communication and Relationship Building: Articulate Quality and Regulatory services benefits to pharmaceutical clients and build lasting relationships with key industry leaders.

Qualifications

• 8+ years of experience with a Bachelor of Science degree, in a related scientific discipline, or 5+ years of experience with a higher-level degree
• Supervisor/manager experience, experience managing at least one direct report, or strong aptitude for management.
• Expertise in development and commercial product lifecycle (Design Control or Clinical Phase 1-3, Marketed combination products).
• Experience with creating and managing Design History Files in accordance with ISO 13485 and FDA 21 CFR 820.30.
• Experience with Risk Management – top down and bottom up analysis.
• Experience with Human Factors Engineering.
• A thorough understanding of IND, BLA, NDA, MAA, and combination product processes such as Notified Body Opinion.
• Strong knowledge of US and international GMP quality regulations, current industry practices, and experience with interpretation and application to development projects and marketed combination product regulatory issues.
• Demonstrated experience in effective collaboration with multiple stakeholders both internally and externally including customers, FDA, and other Health Authorities.
• Demonstrated ability to coach, train, and mentor teams.
• Strong negotiating skills and ability to think creatively and develop creative solutions.
• Ability to prioritize and handle multiple projects simultaneously.
• Excellent interpersonal, oral, and written communication skills as well as strong organizational skills with demonstrated ability to manage and adhere to timelines.
• Proven ability to build trust and respect within the organization and external partners.

Additional Ideal Qualifications

• Prior success in filing marketing applications, supplements, and variations for biologic products within timelines is required, and global submission experience is desired.

Location

• Chicago, IL - Hybrid (Three days onsite, two days remote)
• There is a travel requirement of up to 30%

Employment Type

• Direct Hire

About Ventura Solutions

Ventura Solutions is a reputable end-to-end medical device and combination product consulting, staffing, and training firm. With our deep industry expertise spanning medical devices and combination products, coupled with an outstanding talent pool, we stand out as the preferred option for a diverse array of projects. On the consulting side, we integrate seamlessly into your team and manage small to complex Statement of Work (SOW) projects. On the staffing side, we help source, screen, and on-board reputable employees to fill temporary, temp to permanent, and permanent job openings. We accelerate product development, keep products compliant, and help build great organizations. For more information, visit us at www.ventura-solutions.com.

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