Strictly NO C2C!!!
What are the top 3-5 skills, experience or education required for this position:
- Design History File product lifecycle management experience
- Engineering degree, bioengineering, chemical or mechanical engineering degree
- On-market supplier changes
- Knowledge with applicable global regulatory requirements and industry standards (MDR requirements, ISO 13485, ISO 14971, ISO 10993, etc.)
- Exceptional written and verbal communication skills, and the ability to clearly articulate development challenges and implementation strategies to stakeholders across a broad range of functional groups at all layers of the organization including external vendors
Reason:
- The Combination and Medical Device Products Consumable Device US team is expanding their support for on-market devices.
- This role will be responsible for on-market change execution, product life cycle management, and manufacturing support specific to the product design.
Skills:
- Proficiency with medical device/pharmaceutical DHF traceability required.
- Proficiency with test execution, deviation of reporting and management, data review, and report writing is required.
- Experience with medical device EU and/or FDA. In addition to product support, you will also be responsible for standardizing and simplifying activities within the team to enable more efficient development and marketed product support.
Requirements:
- Bachelor of Science degree with 5+ years of experience, in medical device or pharmaceutical development roles.
Desired:
- Graduate degree in a technical or scientific field.
- Prior experience of consumable medical device/pharmaceutical development.
Pay: $40.00 per hour
Benefits:
Work Location: In person
