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
Responsible for supporting business development activities regarding regulatory due diligence
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
Sufficient computer skills (e.g., MS Word, MS Excel, MS PowerPoint, etc.)
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
Employer will assist with relocation costs.
Internal Number: R-361003
BD is a leading global medical technology company that creates medical technology, devices and laboratory equipment for a variety of needs across the healthcare continuum. At BD, we are looking for candidates who possess passion, innovative solutions and a commitment to our one mission of improving access to groundbreaking medical and biotechnology services for people near and far, delivering state-of-the-art technology and cutting-edge research in the battle to fight and cure infectious diseases. With a global reach that extends across 50 countries worldwide, our network of professionals collaborates on effective measures to deliver enhanced patient quality such as lower health care delivery costs, improved health care and safety, and expanded health care for all. Join our company and see how you can become a part of one global mission to make a difference in human health.
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.