Job Description Summary

As a Clinical Evaluation Lead you will be responsible for providing leadership and support for the development and creation of Clinical, Scientific, and Regulatory documents in accordance with GE HealthCare procedures, the European Medical Device Regulation, US FDA requirements, China NMPA requirements, and global regulations. This includes, conducting literature reviews, assisting, and writing Clinical Evaluation Reports (CER) and Clinical Evaluation Plans in accordance with EU MDR and associated guidances, analysis of product complaints and trends, collecting and analyzing feedback from various sources to support global CER documentation. This person will provide critical expertise and guidance for cross-functional teams from the planning to execution phases to ensure the clinical documents meet the highest standards and provide the necessary data to support marketing applications.

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Job Description

Essential Responsibilities

• Serves as the point person, and participates within the clinical evaluation team for the development and generation of Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in accordance to MEDDEV 2.7/1 Revision 4 and in alignment with EU MDR and MDCG guidance. Contribute to the Summary of Safety and Clinical Performance. Serves as the expert on these clinical regulations and guidances to help teams develop the strategy and ensure the final execution is in line with expectations. Lead trainings for cross-functional teams to help ensure consistency in the execution of clinical documents across businesses.

• Participates in the Post-Market Clinical Follow-up (PMCF) planning, development and execution. Specifically contributes to the literature review and the identification and analysis of clinical data related to the PMCF evaluation.

• Perform or support the completion of comprehensive systematic, documented literature reviews using various resources in order to support the Clinical Evaluation, Post-market Clinical Follow-Up, awareness of current State of the Art as well as protocol development and any ad hoc reports required.

• Analyze available clinical evidence (data held by the manufacturer, published literature) to evaluate the safety and performance of the subject device under evaluation.

• Strong medical and technical writing skills.

• Knowledge and understanding of proposed and current global regulations and guidance and the ability to relay the impact of such regulations and guidance internally. Ensures documents are produced in accordance with procedures, internal and external guidelines (e.g. MEDDEV 2.7.1 Rev. 4).

• Knowledge of clinical research and regulatory requirements.

• Perform other non-routine duties as assigned by the Supervisor

Qualifications/Requirements

• Bachelor's degree from an accredited university or college (or a high school diploma / GED with at least 6 years of experience in healthcare industry or relevant scientific discipline

• 3-5 year’s medical writing experience.

• Direct experience working on clinical evaluations within the Medical Device industry a plus.

• Medical writing certification a plus

Desired Characteristics

• Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills.

• Well organized and structured; high attention to detail

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

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While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Additional Information