Senior Regulatory Affairs Specialist
CooperVision - Pleasanton, CA

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Seeing things in a different light is just the beginning at CooperVision. Our visionaries put ideas into action, raise the bar on product excellence and create the next generation of contact lenses. And now, so can you. Join our team and become a part of a world class organization that is the second largest contact lens manufacturer in the United States and the third largest in the world. A global powerhouse, we tout a network of facilities that expands our reach to 70 countries.

We offer some of the most respected brands and most advanced lenses in the industry, including our recently launched silicone hydrogels Biofinity® & Avaira® which offer the best vision possible in a soft contact lens. Our Proclear Compatibles® lenses deliver unmatched all day comfort. And our Frequency® 55 Multifocal lenses use a revolutionary two-lens system to help correct presbyopia.

Realize your vision ....

JOB TITLE: Senior Regulatory Affairs Specialist

DEPARTMENT: RA/QA

JOB SUMMARY

Responsible for filing necessary applications and for government interactions pertaining to products requiring governmental approval .

ESSENTIAL FUNCTIONS

Develop procedures to ensure regulatory compliance

Generate US regulatory submissions (i.e. PMA, PMA supplement, PMA Annual Reports, 510(k)) to US FDA, Canada and other international/global medical device regulatory agencies.

Prepare and maintain filings and applications (i.e. FDA Annual Reports, international licensing) in support of commercial distribution of products.

Maintain regulatory files and documents in addition to international regulatory tracking documents. This includes maintaining communication with Manager and other departments to provide regional status reports (monthly, quarterly, etc.).

Keeps abreast of regulatory requirements, including monitoring FDA and other agencies regulations and standards.

Review product labeling and marketing material and initiate new package inserts and other required product labeling.

In addition to the required technical documentation, supply samples, packaging, manufacturing site quality system certificates, and certificates of free sale, etc. for global product registrations.

KNOWLEDGE, SKILLS AND ABILITIES

Strong communication (both verbal and written), mathematic/analytical/PC skills.

Flexibility and the ability to manage multiple priorities required.

Good working knowledge of US and non-US regulations that affect Class II or III medical devices required.

Detail oriented and has the ability to work independently.

Manage time effectively and maintain a high level of organization required.

Knowledge of adverse event reporting and international vigilance reporting is preferred.

EDUCATION

Bachelor's degree and working knowledge of FDA regulations.

EXPERIENCE

Minimum 3-5 years general medical device regulatory experience and/or demonstrated skills in a regulatory affairs environment required..

CooperVision is an EEO/AA Employer M/F/D/V

CooperVision - 19 months ago - save job - block
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About this company
32 reviews
CooperVision wants you to be able to clearly see the benefits of its products. CooperVision (CVI) is a leading manufacturer of contact...