Randstad is seeking a Clinical Evaluation Manager for a long term project at one of its biotechnology clients in Marlborough, MA. This client is a leading developer, manufacturer, and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood, and aid in biomedical research. You will work in an atmosphere that is stimulating, innovative, and customer focused.
In this role you'll be compiling Clinical Evaluation Plan (CEP), Clinical Evaluation Reports (CERs), Post Market Clinical Follow-up Plans (PMCFP) and Post Market Clinical Follow-up Reports (PMCFR).
You'll be working across several functions, such as regulatory, R&D, quality and others to develop comprehensive documentation. You'll also work with our Internal Clinicians to ensure that the relevant External Clinical Experts and Clinical Statisticians are engaged in the clinical assessment process as well as ensuring that the clinical requirements of the Active Implantable Medical Devices Directive and Medical Device Regulations are being met. This position reports to the Director of Clinical Research.
Duties & Responsibilities:
- Support detailed gap assessments of entire divisional product portfolio with respect to CEP, CER, PMCFP and CMCFR
- Review, plan, draft and revise CEP, CER, PMCFP and PMCFR for assigned medical device and therapeutic areas
- Coordinates and participates in data collection and evidence synthesis in support of related clinical evaluation report creation and revision activities
- Participate in the development and monitoring of metrics for CERs and SOP/Governance documents to provide visibility of issues and enable corrective and preventive action to be taken as needed
- Liaise with divisional and corporate MDR/IVDR steering committee as necessary
Working hours: 8:00 AM - 5:00 PM
- Must have exceptional judgment, integrity, and ethics to work collaboratively across multiple levels of the organization and lead influentially.
- Flexible and able to work on multiple projects with aggressive timelines. Must be hard-working, energetic and passionate about making a difference with the highest integrity; committed to ethics and scientific standards.
- Understand and effectively communicate scientific and medical information. Excellent written and oral communication skills are imperative.
- Work independently, yet engage in collaborative decision making, to complete tasks in a timely fashion, and function in a rapid-paced environment.
- Establish strong relationships with key functions including regulatory, quality, etc.
- Experience in medical device is required as well as expertise in MEDDEV 2.7.1 rev 4 and knowledge of 2017 EU MDR/IVDR regulations
- BS, Nurse, Masters degree or Ph.D. in applicable medical field or over 3 years of medical or scientific writing experience within a medical device company.
- Knowledge of 2017 EU MDR/IVDR regulations and experience with documentation of MDD
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