Regulatory Affairs Specialist II

Job Title: Regulatory Affairs Specialist II Location: Middletown, VA 22645 Duration: 6+ Months (contract) Shift: Monday – Friday I. SUMMARY: Job Description: The Regulatory Affairs Specialist will join existing team and provide support for Regulatory Affairs activities for IVD products. Tasks will include · Regulatory document management: Initiate, collect, organize, update, and maintain regulatory documentation per department and company procedures; maintain logs and trackers. · Submission preparation: Draft reports and assemble documentation for international regulatory submissions. · Global coordination: Collaborate with international counterparts and partner-channel regulatory teams to secure product approvals, renewals, and related clearances. · Legalization and certification: Request and track document legalization, apostille, and certificates from regulatory agencies. · Collaboration: Maintain positive, cooperative communication with employees at all levels and external partners. · Additional duties: Perform related tasks as assigned. Keys to Success: · Bachelor's degree required, preference for majors in Science or Engineering. · 2+ years of experience working in medical device or IVD focused regulatory affairs. Experience with EU IVD regulation a plus. · Excellent written and verbal skills; able to communicate effectively across organizational levels. · Strong organizational skills; able to prioritize, multitask, and meet deadlines; capable of handling complex projects. · Able to produce clear, accurate technical/regulatory documents with strong attention to detail. · Proficient in MS applications (Excel, Word, Outlook). · Experience of FDA databases a plus.