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Regulatory Affairs Associate

Dublin, CA, USA

Step out of your comfort zone, excel and redefine the limits of what is possible. That’s just what our employees are doing every single day – in order to set the pace through our innovations and enable outstanding achievements. After all, behind every successful company are many great fascinating people.

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

We are looking for people who are keen to try something new:

• Perform the following functions with some supervision:
• Support Regulatory Affairs Team in worldwide medical device registration/re-registration
• 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
• Train and adhere to regulatory processes
• Retain regulatory records – electronic and hardcopy
• Maintain other regulatory logs
• Perform other tasks, as assigned

You are:

• Bachelor’s degree; degree in a scientific discipline a plus
• Two years of work experience; experience in a regulated industry; experience in regulatory affairs a plus
• Experience in a fast-paced, multi-tasking, customer-facing environment with deadlines that required strong attention-to-detail and positive outcomes
• Experience encountering ambiguous situations and determining when to escalate to management
• Strong verbal and written communication and interpersonal skills
• Strong time management and organizational skills
• Strong computer skills including MS Office
• Knowledge of US, EU and international medical device regulations a plus
• Certified Notary a plus
In a spacious modern setting full of opportunities for further development, ZEISS employees work in a place where expert knowledge and team spirit reign supreme. All of this is supported by a special ownership structure and the long-term goal of the Carl Zeiss Foundation: to bring science and society into the future together.

Join us today. Inspire people tomorrow.

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.

Apply now! It takes less than 10 minutes.
We are an EEO/Disabled/AAA/Veterans employer

Diversity is a part of ZEISS. We look forward to receiving your application regardless of gender, nationality, ethnic and social origin, religion, philosophy of life, disability, age, sexual orientation or identity.
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Your contact
Jo Anne Mittelman
joanne.mittelman@zeiss.com
+1 (925)557-4307
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