Regulatory Affairs Specialist

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Skills you'll use

What you'll do

• Regulatory Support:
• Assist in preparing technical documentation and submissions for Class I, IIa, and IIb medical devices in compliance with EU MDR and US FDA 510(k).
• Support country-specific registration processes (e.g., China NMPA and other international markets).
• Participate in the evaluation of regulatory impacts for design changes such as ECRs, PSM decisions, and updates to claims matrices.

Who can apply

• Bachelor’s/Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• 3–5 years of experience in Regulatory Affairs for medical devices.
• Strong working knowledge of EU MDR and US FDA 510(k) requirements.
• Exposure to multi-country registrations and clinical evaluation processes like CER and PMS is preferred.
• RCC or equivalent certification is a plus.
• Familiarity with technical documentation structure is an advantage.
• Strong MS Office and documentation skills.
• Other Attributes
• Strong attention to detail and structured problem-solving skills.
• Effective communication and collaboration abilities in global cross-functional teams.

About ZEISS

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