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Regulatory Affairs Specialist II

Careers Integrated Resources Inc

Middletown, VA

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JOB DETAILS
SKILLS
Communication Skills, Detail Oriented, Document Management, Document Tracking, Documentation, Establish Priorities, FDA (Food and Drug Administration), Medical Equipment, Microsoft Excel, Microsoft Outlook, Microsoft Word, Multitasking, Organizational Skills, Presentation/Verbal Skills, Regulations, Regulatory Submissions, Reporting Skills, Technical Writing, Time Management, Writing Skills
LOCATION
Middletown, VA
POSTED
11 days ago

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.




About the Company

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Careers Integrated Resources Inc