Report this job

---

What is the problem? *

Incorrect company
Incorrect location
Job is expired
Job may be a scam
Other

Responsibilities:

• Collaborates with Quality, providing Medical /Clinical input into the medical device Periodic Safety Update Reports (PSUR) and Post Market Surveillance Reports (PMSR).
• Participates on EU MDR Labeling and other EU MDR Project Teams as the Medical Affairs Core Team Member
• Reviews and provides input into Post Market Clinical Follow-up (PMCF) plans and provides support for the execution of the required PMCF activities.
• Authors publications, study summaries, Clinical Assessment Reports and 'White Papers' to support regulatory submissions and marketing requirements
• Provides guidance and expertise for clinical evidence generation (safety / efficacy / usability) required primarily for EU MDR
• Collaborates with Corporate Clinical Development to provide input and support for Clinical Trials with BD products such as for the purpose of Registrations, Claims Support, and Product Validation in support of EU MDR activities.
• Collaborates with the EU MDR Medical Writers to provide input into EUMDR Clinical Evaluation Reports
• Supports functional management and the Business Unit Director, Medical Affairs in developing the Medical Affairs Strategy to support development, approval, and marketing of new or modified products.
• Collaborates with the product development teams, creates or provides input into risk management assessment and documentation.
• Provides guidance and expertise for clinical evidence generation
• Collaborates with Corporate Clinical Development to provide input and support for Clinical Trials with BD products such as for the purpose of Registrations, Claims Support, and Product Validation.
• Collaborates with the Marketing, R&D and other functions in the development, execution and documentation of product preference studies or surveys and in gathering voice of customer.
• Collaborates with the project team to provide input into PMS / PMCF activities
• Participates in the review and evaluation of customer complaints related to product issues / functionality.
• Assists in the follow up to complaints, the investigation of any product quality issues and the assessment and documentation of the potential health risk associated with product complaints and MDRs as directed.
• Reviews and Evaluates MDS ACRs to identify MA requirements and provides MA assessment, primarily for EU MDR projects

Requirements:

• Minimum of a Bachelor's degree in health related field (Registered Nurse, Nurse Practitioner, MD, DO) required. Advanced degree preferred.
• Minimum 5 years' experience in a hospital care clinical setting
• Previous medical device or pharmaceutical industry experience preferred
• Basic understanding of statistics and clinical trial design
• Proficiency with MS Office applications
• Excellent interpersonal skills, including the ability to perform well in a highly matrixed environment, and to serve as an effective member of multidisciplinary team
• High degree of critical thinking skills
• Excellent organizational skills.
• Strong written and verbal communication skills; ability to create and organize technical / medical documentation.
• Travel 30% worldwide
• Will be supervised by the Senior Medical Specialist, Medical Affairs Manager, Associate Director or Business Unit Director, Medical Affairs and the VP Medical Affairs for BD Medical / MDS