Regulatory Affairs Specialist II

Job Description

Job Summary:

• The Regulatory Affairs Specialist will join existing team and provide support for Regulatory Affairs activities for IVD products.

Responsibilities:

• Tasks will include:Regulatory document management: Initiate, collect, organize, update, and maintain regulatory documentation per department and company procedures; maintain logs and trackers.
• 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.

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.