What are the responsibilities and job description for the Clinical Project Lead II position at Astrix?
Exciting Clinical Project Lead II development opportunity to work for a global leader dedicated to helping people see brilliantly. The largest device company in the world – with complementary businesses in Surgical and Vision Care.
Clinical Project Lead II
6 Month Contract
Fort Worth, TX
Remote is an option/Onsite is Preferred
60.00-65.00
Ophthalmology/Clinical Project Lead II
Seeking a Clinical Project Lead II with expertise in European Medical Device Regulations (EUMDR) to support Life Cycle Management and Post-Production Risk Reviews for ophthalmic medical devices.
Key Responsibilities:
- Serve as the primary POC for the clinical project lead and support in Life Cycle Management/Post Production Life Cycle Management activities
- Review and author clinical regulatory documents for MDR remediation, PPRRs, clinical evaluation documents including risk assessments and literature reviews.
- Provide clinical expertise in regulatory submissions and compliance.
- Participate in cross-functional meetings and training.
Qualifications:
- Master’s/PhD in Vision Science, Optometry, or Ophthalmology.
- Proficiency in EUMDR and clinical regulatory documentation.
- Experience in eye care/ophthalmology preferred.
- Excellent communication and writing skills.
This is an excellent opportunity for a clinical expert with regulatory experience to contribute to the evolving landscape of medical device compliance.
This job description is a complete list of all desired skills but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
Salary : $60 - $65
