Regulatory Affairs Principal Analyst (Remote Opportunity)

The Principal Analyst is the subject matter expert in complex data analysis and performs work independently with minimum supervision. May supervise/act as project lead and provide charts, graphs, data analytics to the Medical Writers to incorporate into regulatory and clinical deliverables as necessary.

Essential Duties and Position Responsibilities

Responsiblefor leading and ensuring completion of all Medical Writing/Analytics Projects by due date

May supervise Medical Writing Analysts including reviewing work products, managing performance, coaching, training and development

Acts as Project Co-leader (with Senior LevelMedical Writer) for all Medical Writing Projects

Performs systematic literature searches utilizing a variety of peer reviewed databases

Creates and updates statistically based Evidence Matrix to supportClinical Evaluation Reports

Creates tables and figures from various data sources including but not limited to FDA MAUDE, FDA TPLC,and other government complaintdatabases (MHRA,SwissMedic,BfARM)

Create various tables and charts necessary for the completion of medical writing deliverables from systematic literature reviews

Create chartsfrom Distiller for medical writing document as necessary

Quality check all calculations throughout the reports for accuracy

Works collaboratively withvarious cross functional group including but not limited to the PMS Group, Field Assurance, Clinical, Medical, Regulatory Affairs and Marketing

Qualifications, Knowledge, and Skills Required:

Minimum10years with B.S. degreelife sciences, engineering or relevant discipline

Minimum3years' experiencewith supervising a high producing team

Extensive experience in statistical analysis of clinical data

Extensive experience analyzing and organizing complex datainto easy to understand and meaningful charts, tables and figures

Extensive experiencewith Microsoft Word, Excel, PowerPoint

Experience with project management

Working knowledge of clinical research, device development processes, regulatory requirements, good clinical and data management practices

Excellent English Language skills, especially in writing and proof reading

Clinical or scientificresearch background required

Extensive knowledge with EU MDR, MEDDEV 2.7.1 Rev 4, GSPR, and IMDRF required

Excellent understanding of scientific or clinical research and methods required

Strong oral and written communication skills

Excellent interpersonal skills

Must be able to handle a variety of projects at the same time

Strong prioritization skills required

Ability to motivate and empower diverse teams

Have an inclusive mindset in working with others

Ability for potential travel (up to 10%)

Key Relationships

Internal Relationships:

• Medical/Clinical Affairs

• Regulatory Affairs Specialist

• Product Development

• Quality Assurance

• PMS Group

• Marketing

• Document Control

External Relationships:

• Corporate Legal and Regulatory Affairs

• Health Ministries

• Notified Bodies, and regulatory agencies (i.e.FDA)

Scope and Impact of Position:

This key position willensure generation and maintenance of clinical statistical evidence to support regulatory submissionsfor all BDI Surgical Business Unit products. This includes a growing line of mesh prosthetics, biologicimplants, fixationsystems, andsurgical instrumentsto complement innovative techniques forvarious surgical procedures.In addition to this extensive suite of products, theBiosurgeryfranchise is deliveringa growingline of enhanced sealants and hemostatic products to complement surgical techniques across, thoracic,cardiovascular,and other surgical specialties.

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.

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