88- Senior Regulatory Specialist

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Job description

Roche Molecular Systems, Inc. seeks a Senior Regulatory Specialist in its Pleasanton, California location.

Responsible for activities which lead to and maintain domestic and international regulatory approvals/clearances to market RMD microbiology products. Represent Regulatory Affairs on project teams and responsible for monitoring and assisting with the activities associated with project plans. Responsible for the coordination and preparation of document packages for regulatory submissions from all areas of the company, including: compiling materials required for submissions, license renewals, and annual registrations and reports. Recommend changes for labeling, manufacturing, marketing, and clinical and development protocols. Oversee the acquisition of documents, records, reports, and data from Development, Clinical Affairs, Quality and Operations Departments for inclusion in regulatory documents. Manage submissions for FDA product approval including 510(k) and Premarket Approvals (PMAs). Interface with regulatory agencies and authorities on regulatory and technical matters, as directed and determine the data requirements and risks for the earliest possible approvals/clearances of regulatory submissions. Review product labeling/advertising to ensure compliance with federal regulations across global markets and review product changes for regulatory impact.

Education and experience required: Bachelor's degree in Clinical Laboratory Science, Chemistry, Biology or related field, and seven (7) years of post-baccalaureate, progressive experience in job offered or related position in regulatory compliance/affairs.

Special Requirements: Position requires 5 years' experience with each of the following:

• Diagnostics product knowledge
• Global Regulatory requirements
• Managing assembly of complex regulatory submissions List all special requirements here, including any travel requirement:

Worksite: 4300 Hacienda Drive, Pleasanton, California, 94588

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

If you have a disability and need an accommodation in connection with the on-line application process, please email us at .