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Regulatory Affairs Senior Specialist
2 months ago
Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their journey. Our extensive range of transformative technologies encompasses various healthcare sectors, including diagnostics, medical devices, nutritionals, and branded generic medications. With a workforce of 114,000 professionals, we serve communities in over 160 countries worldwide.
Position Overview:
The role of the Senior Regulatory Affairs Specialist is a vital on-site position within our Abbott Vascular Division, located in Santa Clara, CA. This position is designed for an individual contributor who will play a crucial role in supporting the regulatory department to maintain efficient and compliant business operations.
Key Responsibilities:
- Strategic Planning: Provide regulatory insights for product lifecycle management and assist in formulating regional regulatory strategies.
- Premarket Activities: Evaluate quality, preclinical, and clinical documentation for submission, prepare regulatory submissions, and monitor the impact of evolving regulations.
- Postmarket Responsibilities: Maintain licenses and registrations, ensure compliance with post-marketing requirements, and assist in label development and review.
Qualifications:
Applicants should possess a Bachelor's Degree in a relevant field or an equivalent combination of education and experience. A minimum of 3-4 years of experience in a regulated industry, such as medical products or nutritionals, is required. Preferred candidates will have 2-3 years of regulatory experience, though backgrounds in quality assurance, research and development, or scientific affairs may also be considered.
Skills:
Candidates must demonstrate strong verbal and written communication abilities, organizational skills, and attention to detail. The ability to navigate complex information and exercise sound judgment within regulatory frameworks is essential.
Preferred Qualifications:
A degree in a science or technical discipline, along with previous experience in PMA/IDE and international submissions, is advantageous. Familiarity with IDE trial strategies and post-market clinical activities will be beneficial.
Abbott is committed to fostering a diverse and inclusive workplace, ensuring equal opportunities for all employees.
