Associate Director, Regulatory Affairs

BD (Becton, Dickinson and Company) Veterans Jobs

Associate Director, Regulatory Affairs in Covington , Georgia

Job Description Summary

Job Description

The Associate Director, Regulatory Affairs is a key leadership role in the Division and is responsible for supporting the product life cycle through regulatory strategy; driving revenue; conducting the selection, orientation, development and mentoring of regulatory professionals within the department; and participating where appropriate in corporate and industry regulatory initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES including the following. Other duties may be assigned.

An active department leader that helps drive strategic planning, decisions and success for the organization

Plan, coordinate and manage work of Regulatory Affairs department

Provide direct management , supervision, career path development and mentoring to direct reports as appropriate

Implement company and departmental goals, objectives, and enforce requirements of quality work

Mentoring the members of the Regulatory Affairs department in product development / SE teams as required ensuring that the product is in compliance with all internal and external regulatory requirements

Responsible for U.S. FDA 5l0(k), IDE, submissions as required; ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet standards

Responsible for the updates of European and international product dossiers/registrations as required; ensure that all submissions are accurate and completed in a timely manner, and that all arguments presented in the submission are appropriate, defendable, scientifically based and meet standards

Responsible for regulatory review and guidance for all regulatory post market activities including product labeling and advertising and promotional material and post market surveillance

Review all clinical and marketing study protocols for compliance with FDA, European, and international regulations and standards.

Responsible for the review of FDA submissions and labeling

Responsible for assuring requirements for establishment registrations and device listings

Develop Procedures, implementing FDA, European, and international regulations and standards as appropriate

Ensure adequate documentation of compliance to FDA, European, and international regulations and standards. Ensure continuous update and maintenance of the Regulatory Affairs files

Develop working relationships with key personnel/representatives of the U.S. FDA Offices , and notified body

Responsible for contract review considerations regarding regulatory roles and responsibilities for global product submissions

QUALIFICATIONS

Must be able to maintain confidentiality in dealing with regulatory and clinical documentation

Must have excellent written and verbal communication skills

Must be a team player

Must be able to prioritize and handle several projects concurrently

Must be self-motivated by working independently and having the ability to take ownership of her/his responsibilities

Must be able to meet goals on time

Must have knowledge of the U.S.A. Federal Regulations for medical devices including those applicable to the import/export of devices

Must have knowledge with the requirements for medical device registration/licensing in the EU, Japan, Canada, Australia, Latin America and Asia/Pacific

EDUCATION AND/OR EXPERIENCE:

BS in a scientific discipline with 10 years of employment in the areas of medical device registration, compliance or quality systems including 5 years of personnel management experience

Regulatory Affairs Certification (RAC), advanced Degree and Certifications desired

Comprehensive knowledge of United States, European, and/or international regulations and standards covering medical devices required

Knowledge of the clinical application of medical devices, as applicable

Knowledge of medical device testing methods and statistics, as applicable

Excellent project management skills, with the ability to prioritize and delegate, handling several projects concurrently

#LI-TECH

Primary Work LocationUSA GA - Covington BMD

Additional Locations

Work Shift

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.

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.

All applicants should complete the on-line application process. BD is committed to working with and providing reasonable accommodations to individuals with disabilities. If you require assistance or an accommodation because of a disability to participate in the application process, please call 855-BD-HELPS (855-234-3577) or email asc.americas@bd.com