Staff Regulatory Affairs Specialist at ZEISS Meditec Production in Dublin, California

Job Description:

STAFF REGULATORY AFFAIRS SPECIALIST

DUBLIN, CA

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 Staff Regulatory Affairs Specialist is responsible for the development, labeling, documentation, regulatory strategy, submissions, registration, change impact assessment, and promotion of software driven ophthalmic electromedical devices in compliance with US, EU and international medical device regulations including, but not limited to, AU, BR, CA, CN, JP, KR, MX, RU. The Staff Regulatory Affairs Specialist is expected to manage initiatives and projects with minimal supervision.

WE ARE LOOKING FOR PEOPLE WHO ARE KEEN TO TRY SOMETHING NEW:

* Perform the following functions with minimal supervision:
* Product development cross-functional core team regulatory support
* Regulatory strategy determination for US, EU and international markets (see summary)
* Device regulations and standards compliance - US, EU and international markets (see summary)
* Labeling compliance
* EU Technical file preparation Compliant to MDD and MDR
* Summary Technical Document (STED) preparation - EU and international markets
* International registration submissions preparation in partnership with ZEISS Affiliates and dealers
* 510(k) submission preparation in partnership with US Regulatory Submissions Team
* Worldwide registration and re-registration
* Promotional material compliance
* Product change impact assessment
* Regulatory surveillance and organization response to changes in laws, regulations and standards
* Regulatory status report preparation; present to the organization, as assigned
* Represent Regulatory Affairs to Regulatory Authorities and auditors, as assigned
* Represent Regulatory Affairs within the organization as well as with external associates
* Lead local and global projects, as assigned
* Train and coach less experienced members of the Regulatory Affairs Team
* Mange assigned initiatives and projects
* Adherence to regulatory processes
* Perform other duties, as assigned

YOU ARE:

* Experience developing software driven electromedical devices; ophthalmic devices a plus
* Experience with EU and international registration; US a plus
* Experience working in cross-functional teams; leading teams a plus
* Experience supporting multiple projects and product lines concurrently with successful outcomes
* Experience evaluating and communicating technologically complex medical devices and principles
* Includes authoring comprehensive regulatory documents (e.g. clinical strategy plans, STEDs)
* Experience developing and communicating regulatory strategy
* Experience applying US, EU and international medical device regulations
* Strong verbal and written communication and interpersonal skills
* Strong prioritization, time management, project management and attention-to-details skills
* Strong negotiation, influencing, consensus building, and relationship building skills
* Strong analytical, problem-solving and decision-making skills
* Strong computer skills including MS Office, MS Project a plus
* Minimum Bachelor s degree in a scientific or engineering discipline; Master s degree a plus
* Minimum of six years of experience in a regulated industry with a minimum of five years of experience in regulatory affairs
* Industry recognized certification (e.g. RAPS RAC) 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/AAA/Disabled/Veterans Company

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.