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Job Requirements of Regulatory Affairs Specialist II:
-
Employment Type:
Contractor
-
Location:
Middletown, VA (Onsite)
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Regulatory Affairs Specialist II
Careers Integrated Resources Inc
Middletown, VA (Onsite)
Contractor
Job Title: Regulatory Affairs Specialist II
Location: Middletown, VA 22645
Duration: 6+ Months (contract)
Shift: Monday – Friday
I. SUMMARY:
Job Description:
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.
- 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.
- 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.
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