Are you excited about utilizing your device design control skills and collaborating with highly skilled professionals? Do you aspire to have complete ownership of your portfolio and play a crucial role in driving scalability, all while engaging with stakeholders at all levels?
If so, then join us in Device Manufacturing Development (DMD) Device Development and take responsibility for some of our largest products. Don’t miss out, apply now!
The Position
As Product Responsible for our medical devices and combination products, you lead the post-launch phase of our product pipeline, overseeing device documentation, including delivery system platforms and design control documentation. You ensure a balance between regulatory and internal requirements while collaborating with various stakeholders for effective problem-solving.
Some of your key tasks include:
Leading and driving existing device documentation activities, covering areas like mechanical design, requirements engineering, design verification, and safety risk management
Collaborating closely with Regulatory Affairs to ensure ongoing compliance and the update of device documentation
Maintaining a comprehensive understanding of technical documentation and delivering high-quality work
Contributing to continuous improvement in our daily activities and support process improvement initiatives
Qualifications
To be successful in this role, we imagine you:
Hold a master’s degree in engineering, biomechanics, science, manufacturing, pharmaceutical, or a related field
Bring a minimum of 5 years of relevant experience in drug devices/combination products within regulatory affairs, project, or portfolio management roles in the medical device or pharmaceutical industry
Demonstrate strong networking and stakeholder management skills to provide direction, drive performance, and ensure quality, speed, and agility in a complex environment
Have knowledge of design control regulations, such as 21 CFR Part 820 and 21 CFR Part 4
Showcase proficiency in both spoken and written English
