Clinical Scientist - EU MDR (Remote)
Job Description Summary
Be part of something bigger!
BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. We have over 65,000 employees and a presence in virtually every country around the world to address some of the most challenging global health issues.
The Clinical Scientist is responsible for performing, preparing, and maintaining clinical evaluations for CE technical documentation in accordance with the requirements of ISO 14155 and MEDDEV.2.7.1, and EU MDR. This primarily involves analyzing available safety and performance data for a medical device (e.g., from clinical trials, published literature, etc.) and preparing technical reports (Clinical Evaluation Reports) to demonstrate the device’s technical and clinical performance. This role will support Technical Documentation (TD) remediation efforts to support EU MDR certification submissions.
This position is a limited term assignment which will include benefits such as (medical, health, dental, 401k). Eligibility for these benefits will be based on the eligibility requirements as determined by the BD Total Rewards policy, and is anticipated to last approximately through September 30, 2024.
ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.
Participate as the Clinical Representative in Cross-functional teams. Prepare Clinical Evaluation Plans (CEPs) and Clinical Evaluation Reports (CERs) for technical documentation in compliance with applicable regulations (e.g., MEDDEV 2.7.1, ISO 14155, EU MDR, etc.) and company procedures.
Perform clinical evidence gap assessments for assigned project teams, Update existing CERs to meet EU MDR regulation standards.
Collaborate with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives. Responsible for ensuring that assigned plans and reports are self-checked for errors, grammar, accuracy before approval, and that documents are routed correctly in the document control process. Responsible for following up on approvals of documents and ensuring that the CERs are released in the electronic document system timely.
Obtain required approvals and ensure that Clinical Evaluation readiness according to the required EU MDR Submission schedule. Participate in work streams and or process improvement initiatives.
Other duties as assigned (i.e Post-Market EU MDR project assignments)
Bachelor's degree in a relevant field or clinical/medical subject area (e.g., Biology, RN, PA, etc.) with 5 years of professional experience.
Master’s Degree, Medical Doctor, Nurse, Pharmacist, Doctor of Philosophy in a relevant field or clinical/medical subject area with 5 years of professional experience is strongly preferred.
Scientific research, medical writing, or medical device industry or a combination of education and experience preferred.
This position requires demonstrated experience in high quality medical/technical writing and excellent written and oral communication skills.
Prior experience performing clinical evaluations according to MEDDEV 2.7.1 and EU MDR, and systematic literature reviews is strongly preferred.
Why join us?
A career at BD means being part of a team that values your opinions and contributions and that empowers you to bring your authentic self to work. Here our associates can fulfill their life’s purpose through the work that they do every day.
You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth-centered, and rewarding culture. Our Total Rewards program — which includes competitive pay, benefits, continuous learning, recognition, career growth, and life balance components — is designed to support the varying needs of our diverse and global associates.
To learn more about BD visit https://jobs.bd.com/
Becton, Dickinson and Company is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Primary Work Location
USA GA - Covington BMD
Primary Work LocationUSA GA - Covington BMD
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"Purpose driven company where associates work every day to make healthcare better. A lot of great initiatives going on to make BD the best MedTech company in the world."
Anonymous, Franklin Lakes, NJ