Primary Purpose and Geographical Scope: As a key member of the Electronic & Commercial Devices team within the Devices, Packaging & Wearable Technologies organisation, this role focuses on ensuring the technical quality and life cycle management of drug delivery technologies and medical devices globally. Reporting to the Electronic & Commercial Devices Head, the position contributes to cross-functional technical program teams for the design, development, industrialisation, and life cycle management of medical device programs.
- Perform technical activities supporting on-market and life cycle management of medical devices, including design, development, and industrialisation within cross-functional technical program teams.
- Contribute to technical medical device activities related to market feedback, life cycle management, and maintenance of technical quality with internal and external partners.
- Project planning, tracking, and anticipation of program challenges within program teams.
- Ensure compliance with combination product and medical device quality management systems, collaborating closely with quality assurance and medical device vendor management teams.
Education & Qualification:
- Education Level: Bachelor's Degree (Master's or Ph.D. preferred)
- Proven track record in project management, medical device development, industrialisation, production, and quality.
- Pharmaceutical business experience with knowledge of the competitive landscape, drug development process, health economics, and health outcomes.
- Knowledge of Good Manufacturing Practice (e.g., ISO 13485, 21 CFR820, Medical Device Directive) and evolving regulatory expectations.
- Project management skills, including evaluation of external projects and technologies.
- Familiarity with HS&E processes and procedures.
- Minimum 1 - 2 years in the pharmaceutical/biologics/medical device industry.
- Practical understanding of ISO13485, 21CFR820, 21CFR210/211, 21CFR4, ISO14971, ICHQ9, MDR requirements.
- Green Belt and/or Project Management certification preferred.
- Delivering Solutions: Understands the role of technology and devices in Company portfolio, capable of analysing and evaluating all available technical information.
- Decision Making: Proposes and contributes to decisions on medical device programs.
- Communications: Effectively communicates complex technical data internally and externally.
- Accountability & Financial Management: Accountable for ensuring all technical activities meet customer and stakeholder requirements and comply with applicable regulatory and quality systems requirements.
Join us in shaping the future of medical devices. Apply now to contribute to cutting-edge advancements in healthcare!