Regulatory Affairs Specialist

About Us:

How many companies can say they've been in business for over 177 years?!

Here at ZEISS, we certainly can! As the pioneers of science, ZEISS handles the everchanging environments in a fast-paced world, meeting it with cutting edge of technologies and continuous advancements.

ZEISS believes that innovation and technology are the key to a sustainable future and solutions for global change.

We have a diverse range of portfolios throughout the ZEISS family in segments like, Industrial Quality & Research, Medical Technology, Consumer Markets and Semiconductor Manufacturing Technology.

We are a global company with over 42,000 employees and have over 4,000 in the US and Canada alone! Make a difference, come join the team!

Location/Region: This position is located in Dublin, CA

What's the role?

The Regulatory Affairs Specialist is responsible for supporting the Regulatory Affairs Team in worldwide medical device registration/re-registration of software driven electromedical devices in compliance with US, EU and international medical device regulations including, but not limited to, AU, BR, CA, CN, MX, KR, JP.

Responsibilities include but are not limited to support of local and multi-site Product Development Teams, regulatory strategy, applicable standards, guidances and regulations/directives, CE-Marking, Technical Files, Rest of World registrations, regulatory intelligence and records maintenance.

The position works closely with International Regulatory Affairs to ensure that all products currently being sold by Carl Zeiss Meditec have appropriate country approvals/registrations, and that regulatory submissions for new/modified products are completed to facilitate product launches globally.

The Regulatory Affairs Specialist is expected to perform tasks with training and some supervision.

Sound Interesting?

Here's what you'll do:


* Facilitate worldwide medical device registrations/re-registrations


* Assist in creation, compilation, duplication, distribution and retention of regulatory submissions


* Obtain document notarization, apostillization, legalization, as needed


* Serve as legal manufacturer point of contact for International Affiliates and dealers regarding registration activities


* Archive and retrieve documents to/from electronic documentation system


* Coordinate documentation transmission - electronic large file transfer /courier


* Maintain registration submission and status log; provide status reports


* Escalate issues and questions to Regulatory Affairs Team and/or Manager

Do you qualify?


* Requires a Bachelors degree in an appropriate scientific discipline.


* A minimum of three (3) years of medical device regulatory affairs, or industry related experience, with a strong preference for software driven devices.

Global regulatory experience preferred.


* Experience in a fast-paced, multi-tasking, customer-facing environment with deadlines that required strong attention-to...