Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist Location: Franklin Lakes, NJ (Hybrid model). Duration: 12+ months. Client: Medical Device Company. Employment Type: Contract on W2 (U.S. Citizens or GC holders only). New RA position dedicated to the Reusable Pen Platform and its two strategic customers with BD for Pen and Pen needles registered in over 80 countries. This is a contract to hire opportunity to gain hands on experience in regulatory field with business‑to‑business customer exposure, global submission activity, regulatory intelligence reviews, health authority interactions/audits, and project management. Main Responsibilities Ensure timely execution of regulatory strategies and customer deliverables as determined by RA Manager. Manage and execute end‑to‑end activities such as documentation, submissions, and addressing health authority questions for new or renewal of existing medical device registrations of reusable pen and pen needles in worldwide market. Maintain compliant regulatory files and supporting documentation (EU technical files/US master files/international technical dossiers) in worldwide market. Perform regulatory impact assessment of changes related to design, improvements, and customer experience and coordinate supplement/notification/change submissions for timely implementation. Collaborate effectively with multiple stakeholders (internal teams, customers, regulators) for technical requirements and documentation to support regulatory registrations, project deliverables, and audit‑ready folders. Manage multiple projects with attention to detail for health authority submissions and represent RA in internal and external audits by customers and health authorities for compliance to MDSAP, EU‑MDR, ISO 13485 and global compliance. Identify ways to improve the efficiency of current work process and best practices. Education B.S. degree in a technical discipline (e.g., pharmacy, engineering, biology, chemistry). Advanced degree preferred. Experience Minimum of 5 years of directly related work experience in medical device regulatory field. Medical device and international registration experience is a must. Combination products knowledge or experience is a plus. Proficient in using Microsoft Word, Access, Excel, OneNote, Project, and OneDrive/SharePoint. Interpersonal and Social Skills Strong project management and communication (verbal, written) skills. Able to independently handle multiple tasks/projects with minimum supervision. Self‑starter with the ability to take over responsibilities. Team player, attention to details, highly result‑oriented. Flexible and reliable personality; ability to manage stressful situations. High personal integrity and ethical standards. Ability to drive and maintain favorable customer experience and customer‑centricity (internal & external). Location No remote position. Associate must be available onsite. BD provides flexible policy. Why Join Us? You will learn and work alongside inspirational leaders and colleagues who are equally passionate and committed to fostering an inclusive, growth‑centered, and rewarding culture and life balance components — designed to support the varying needs of our diverse associates. #J-18808-Ljbffr MillenniumSoft Inc