BD (Becton, Dickinson and Company) Sr. Regulatory Affairs Specialist (Remote Optional) in Vernon Hills, Illinois
Job Description Summary
This position is responsible for managing the various regulatory activities for new and existing medical devices and/or pharmaceuticals. Examples include, but are not limited to.
Write domestic device and drug regulatory submissions including PMA, 510(k), NDA, ANDA, Prior Approval Supplements (PAS), Changes Being Effected (CBE), Annual Reports, IND, IND Amendments and Regulatory authority responses.
Work with functional representatives from other areas such as R&D, Manufacturing, Medical Affairs, and Quality to review and provide input on regulatory strategy for new products and regulatory impact assessment for product changes.
Review Labeling and Advertising and Promotional materials for compliance to internal procedures.
Manage and maintain the drug and device registrations and listings (FURLS/DURLS) system.
Support the quality system and internal/external audits.
Excellent organizational and communications skills. Candidate should be able to work independently, support project teams, to address and communicate problems and complex issues in a concise and effective manner , to manage multiple projects/tasks simultaneously, and effectively manage and prioritize regulatory submission projects. Experience with MS Word, Excel, PowerPoint, and Adobe Acrobat PRO required. Experience navigating FDA databases required. Experience with EU MDR preferred. Experience with electronic submissions and ERP systems is preferred.
Minimum BS required in science, such as Chemistry, Biology, Microbiology, or engineering. Masters Preferred.
Strong attention to detail and Excellent organizational skills
History of successful regulatory submissions
Project management of regulatory submissions with minimal guidance
Effective verbal and written presentation and communication skills Comprehensive coordination and compilation of documentation
Minimum of 3 years' experience in Regulatory Affairs in Medical Devices and/or Pharmaceuticals. A combination of both preferred.
Minimum of 3 years experience working with the FDA CDRH and/or CDER
Strong working knowledge of US and International regulations and guidance, such as 21 CFR 820, ISO 13485, ICH guidelines and 21 CFR 210/211. Internal auditing experience a plus.
Primary Work Location
USA IL - Vernon Hills
USA RI - Warwick
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.