Clinical Evaluation Lead
Aequor JD ·www.aequor.com
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LOCATION:
Ideally HM would like 3 positions in Fort Worth and 2 positions in Lake Forest, CA
However, remote is OK but a) not the preferred method and b) we need them to be flexible to be able to jump on a plane and be here in FTW (for 2-3 days) if needed.
Job Description Key accountabilities The contractor will be responsible/accountable for the following, - Act as the primary point of contact for the Clinical project lead and provide support in Life Cycle Management/Post Production risk review activities - Activities include but not limited to, understanding and evaluating available clinical data on surgical products, reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities - Provide clinical functional review and expertise on the assigned projects/tasks - Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs), and post-market clinical plans - Develop template for post-market clinical plan activities, including physician surveys, retrospective/prospective studies etc. - Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead/line manager - Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head - Attend Clinical team meetings, Clinical Sub team and Trial Team Meeting and any other project meetings as assigned by the Project Lead/Line Manager and represent the function - Complete training activities to better understand product therapeutic area as assigned by the manager
Strong experience in clinical evaluations of medical devices (ophthalmology preferred) for life cycle management, and remediation for MDR Good knowledge of the European medical device regulations (MDR), MDCG and PMCF requirements for medical devices Prior experience in planning/conducting/reporting physician surveys, registries etc is a bonus Experience in eye care/ophthalmology is preferred Strong communication and writing skills Strong project management and meeting facilitation skills
Ideally HM would like 3 positions in Fort Worth and 2 positions in Lake Forest, CA
However, remote is OK but a) not the preferred method and b) we need them to be flexible to be able to jump on a plane and be here in FTW (for 2-3 days) if needed.
Job Description Key accountabilities The contractor will be responsible/accountable for the following, - Act as the primary point of contact for the Clinical project lead and provide support in Life Cycle Management/Post Production risk review activities - Activities include but not limited to, understanding and evaluating available clinical data on surgical products, reviewing data against MDR and MDCG Guidance documents and conducting gap assessments and remediation activities - Provide clinical functional review and expertise on the assigned projects/tasks - Be responsible for timely authoring (as applicable), revisions, update, on clinical related documents for Medical Device Regulation (MDR) remediation and Post production Risk Reviews (PPRRs), and post-market clinical plans - Develop template for post-market clinical plan activities, including physician surveys, retrospective/prospective studies etc. - Review large documents such as literature reports, clinical research protocols, and review template documents as assigned by the project lead/line manager - Assist in literature review activities as assigned by the project lead and/or CDMA Franchise Head - Attend Clinical team meetings, Clinical Sub team and Trial Team Meeting and any other project meetings as assigned by the Project Lead/Line Manager and represent the function - Complete training activities to better understand product therapeutic area as assigned by the manager
Strong experience in clinical evaluations of medical devices (ophthalmology preferred) for life cycle management, and remediation for MDR Good knowledge of the European medical device regulations (MDR), MDCG and PMCF requirements for medical devices Prior experience in planning/conducting/reporting physician surveys, registries etc is a bonus Experience in eye care/ophthalmology is preferred Strong communication and writing skills Strong project management and meeting facilitation skills
Frequently asked questions
Who is hiring for the Clinical Evaluation Lead role?
Aequor JD is hiring for the Clinical Evaluation Lead position, a Shazamme client. Apply directly on the employer's career site.
Where is the Clinical Evaluation Lead job located?
The Clinical Evaluation Lead role with Aequor JD is based in Fort Worth, TX, US. The role is remote-friendly.
Is the Clinical Evaluation Lead role remote?
Yes — the Clinical Evaluation Lead position at Aequor JD is remote. Candidates based in US are preferred.
Is the Clinical Evaluation Lead role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Clinical Evaluation Lead role?
The Clinical Evaluation Lead position is aimed at lead-level candidates.
How do I apply for the Clinical Evaluation Lead role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.