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Job Description
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1. Sr. Regulatory Submissions Specialist (2 positions)
Location: Milpitas, CA
Full-Time, relocation package is available.
The Sr. Regulatory Submissions Specialist will prepare and submit pre-market applications to the FDA. This position will approve proposed product changes and modifications as well as labeling, packaging, and promotional materials. This position will support preparation of international product pre-marketing, registration applications and approves international labeling and packaging.
The essential functions and major responsibilities of the position are:
1. Plans, prepares and coordinates the development of pre-market applications and related submissions to FDA and other domestic agencies. Provides guidance to product development teams regarding conformance with medical device regulations, data required to substantiate product claims, and content of labeling, advertising, and promotional materials. Interacts with health authorities as required.
2. Develops international product registration and reimbursement applications. Provides guidance to product development teams regarding data and information required to prepare such registrations.
3. Approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to medical device regulations and commitments made in clearance, approval, or registration applications for the product.
4. Reviews and evaluates domestic and international regulatory impact of proposed product changes. Prepares submissions (or rationales justifying no submission) needed to approve such changes.
5. Support domestic and international product removal and correction activities. Performs directed activities and aids in preparation of documentation supporting product liability legal actions and claims. Interfaces with corporate and outside counsel as required. Participates in special assignments as required.
The Sr. Regulatory Submissions Specialist will have key working relationships with internal domestic and international marketing departments, RD&E, clinical research, manufacturing, quality, customer service, and document management.
The Sr. Regulatory Submissions Specialist will also have key working relationships with external US FDA, domestic and foreign regulatory , marketing, and legal personnel, international health authorities, and outside legal counsel.
Education:
- A degree in a professional or scientific discipline related to the practice of medicine and/or a license, registration, or certification permitting administration of health care.
Experience:
- At least 5+ years of medical device, diagnostic, or related industry experience. Demonstrated success in preparing medical device pre-marketing applications. Knowledge and understanding of US and foreign Medical Device regulations is essential.
- Computer literacy required. Excellent analytical capability, communication skills and independent problem solving ability essential. Ability to interface with all levels of management necessary.
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