About this opportunity
The Regulatory Affairs Specialist- Contractor will assist or lead a variety of regulatory tasks in support of global regulatory strategy, regulatory assessment for modified product, regulatory filing for new / modified product, regulatory operation and processes, post-market surveillance.
This role requires strong organization, written and oral communication skills, and must be able to perform tasks with accuracy and a high attention to detail.
Duration is 6 months with possible extension. This position will be based in San Jose, CA. In this role, you will Perform regulatory assessments for product changes including regulatory reportability decisions Work with cross functional team and international regulatory colleagues to develop and implement global regulatory strategy to support business global expansions Support regulatory filing like a 510(k) or Pre-submission or a new / amended Health Canada License application for a Class II new product and may include renewal of Licenses Support international regulatory filing Assist in streamlining or updating regulatory processes Assist in regulatory intelligence activities Assist in post-market surveillance activities, such as complaint handling and vigilance reporting Assist in regulatory involved QMS activities, such as CAPA, Non-Conformance Perform other related assignments as required In this role, you’ll need Bachelor’s degree in Science, Engineering, Regulatory, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
Must be available to work with a hybrid schedule (3 days in office, 2 days remote) in office : San Jose, California 1-2 years experience in medical device industry.
Experience of medical device, SaMD development, or regulatory affairs is preferred Knowledged of US regulation in medical device is required In-depth knowledge and skills with computer applications and business tools such as e-mail, MS Word, Excel, PowerPoint Motivated and quick to learn new concepts and understand technical writing and medical device regulations Proficient written and oral communication skills Organized and detail-oriented Ability to manage work effectively in a remote capacity in a fast-paced, dynamic but often ambiguous workplace
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