Regulatory Affairs Specialist

About Us:

How many companies can say theyve 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 42000 employees and have over 4000 in the US and Canada alone! Make a difference come join the team!

Location/Region: This position is located in Dublin CA

Whats 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

Heres what youll 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-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

We have amazing benefits to support you as an employee at ZEISS!

• Medical
• Vision
• Dental
• 401k Matching
• Employee Assistance Programs
• Vacation and sick pay
• The list goes on!

The yearly pay range for this position is $83100 - $103900.

The pay offered for this role may be influenced by factors such as job location scope of role qualifications education experience & complexity/specialization/scarcity of talent.

This position is eligible for a Performance Bonus.

ZEISS is an EEO/AA/M/F/Disabled Veteran Employer

Your ZEISS Recruiting Team:

Zeiss provides Equal Employment Opportunity without unlawful regard to an Applicants race color religion creed sex gender marital status age national origin or ancestry physical or mental disability medical condition military or veteran status citizen status sexual orientation pregnancy (includes childbirth breastfeeding or related medical condition) genetic predisposition carrier status gender expression or identity including transgender identity or any other class or characteristic protected by federal state or local law of the employee (or the people with whom the employee associates including relatives and friends).