Associate Director, Regulatory Affairs

22 Sep, 2020

Jobs

Associate Director, Regulatory Affairs

BD
Covington, GA

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
  • Responsible for supporting business development activities regarding  regulatory due diligence

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
  • 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

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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Job posted: 2020-09-22