Device Manager

At Adalvo, we're not just a company - we're a team of passionate people driven by our mission to consistently deliver high-quality products and services to our partners. We are positive, fast and always on target, we are Adalvo! 🎯 🚀

We are looking for an enthusiastic Device Manager to join our dynamic Strategic Scientific Affairs team. If you're someone who thrives in a fast-paced environment and loves tackling new challenges, then this is the perfect opportunity for you.

SUMMARY OF POSITION

The Device Manager will be responsible for the technical, development, regulatory, and lifecycle management activities related to Adalvo's Drug-Device Combination Products (DDCPs) and Medical Devices. This role will act as the subject matter expert for device technologies, supporting product selection, development, licensing evaluations, regulatory submissions, technology transfers, and commercial launches.

Working closely with R&D, Portfolio, Regulatory Affairs, Quality, Intellectual Property, Business Development, Supply Chain, and external device partners, the Device Manager will ensure that all device-related activities are executed in compliance with global regulatory requirements while supporting Adalvo's strategic growth objectives.

ORGANIZATION STRUCTURE

The position will report directly to the Senior Director / Head of R&D.

Key cross-functional interfaces include:

·         Formulation Development

·         Regulatory Affairs

·         Quality Assurance

·         Portfolio Management

·         Business Development

·         Intellectual Property

·         Supply Chain

·         Project Management

·         External Device Manufacturers and Technology Partners

RESPONSIBILITIES

Primary responsibilities of this role include the following:

Device Strategy & Technical Leadership

·         Serve as Adalvo's technical lead for medical devices and drug-device combination products.

·         Support product selection, due diligence activities, and technical evaluations of potential licensing opportunities.

·         Define device development strategies aligned with regulatory, commercial, and patient requirements.

·         Provide expert guidance on device selection, usability, human factors, and risk management activities.

Device Development & Lifecycle Management

·         Lead development activities for autoinjectors, pen injectors, prefilled syringes, inhalation devices, nasal delivery systems, and other combination products.

·         Prepare and review device development plans, specifications, technical documentation, and design verification reports.

·         Oversee Design History Files (DHF), risk assessments, device change controls, and lifecycle management activities.

·         Support troubleshooting and continuous improvement initiatives throughout the product lifecycle.

Regulatory & Compliance

·         Ensure compliance with applicable global regulations and standards including MDR 2017/745, ISO 13485, ISO 14971, ISO 11608, ISO 11040, FDA 21 CFR, and other relevant medical device requirements.

·         Support regulatory submissions, deficiency responses, variations, and lifecycle maintenance activities.

·         Review technical files, design documentation, risk management files, and usability engineering documentation.

·         Stay informed of emerging global device regulations and industry expectations.

External Partner & Vendor Management

·         Identify, evaluate, qualify, and manage device manufacturers and development partners.

·         Participate in technical due diligence of suppliers, development organizations, and manufacturing sites.

·         Support quality audits and supplier qualification activities together with Quality teams.

·         Drive collaboration and alignment across internal stakeholders and external partners.

Technology Transfer & Commercial Launch

·         Support scale-up and technology transfer projects from development through commercialization.

·         Ensure readiness of device components, assembly processes, testing methods, and packaging systems.

·         Support manufacturing site implementation, validation activities, FAT/SAT reviews, and launch activities.

·         Collaborate with Project Management to ensure timely execution of milestones and deliverables.

Cross-Functional Collaboration

·         Work closely with R&D, Regulatory Affairs, Quality, Portfolio, Business Development, and Commercial teams to deliver successful projects.

·         Provide device expertise during partner meetings, customer discussions, and licensing evaluations.

·         Support training and knowledge transfer related to device technologies across Adalvo.

QUALIFICATIONS & REQUIREMENTS

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, Biomedical Engineering, Mechanical Engineering, Packaging Technology, or a related scientific discipline.

• Minimum 8 years of pharmaceutical and/or medical device industry experience.

• Demonstrated experience with Drug-Device Combination Products and Medical Devices.

• Strong knowledge of device development principles, risk management, human factors engineering, and usability studies.

• Experience with prefilled syringes, pen injectors, autoinjectors, inhalation systems, or related delivery devices.

• Knowledge of MDR 2017/745, ISO 13485, ISO 14971, ISO 11608, ISO 11040 and FDA requirements.

• Experience supporting regulatory submissions and technical documentation.

• Strong project management and stakeholder management capabilities.

• Excellent verbal and written English communication skills.

Preferred

• Experience working with global CDMOs, device manufacturers, and technology partners.

• Experience supporting ANDA, 505(b)(2), hybrid, or complex generic product development.

• Understanding of intellectual property considerations related to device development.

• Experience with design controls, DHF preparation, usability studies, and risk assessments.

• Exposure to global markets including EU, US, LATAM, and emerging markets.

CORE COMPETENCIES

• Business Focus

• Strategic Thinking

• Results & Operational Excellence

• Collaboration

• Quality

• Innovation & Continuous Improvement

• Change Agility

Why join us?

🎯 Exciting Challenges: Every day brings new opportunities to learn and grow.

🎯 Supportive Environment: We foster a culture of collaboration, where your ideas are valued, and your voice is heard.

🎯Career Development: We're committed to helping you reach your full potential through ongoing training and development opportunities.

🎯Recognizing Excellence: We recognize and appreciate hard work and dedication by offering competitive compensation packages and employee rewards programs that acknowledge contributions and achievements.

🎯Fun and Inclusive Culture: We believe in celebrating our successes and building strong connections within our team.

Ready to Ignite Your Passion?

If you're ready to take the next step in your career and join a business committed to consistently deliver high-quality products and services, then we want to hear from you! Send us your resume today!