Abbott Regulatory Affairs Specialist - Endovascular in Santa Clara, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support for the regulatory department to ensure efficient and compliant business processes and environment. The individual may execute tasks and exercise influence generally at the middle management level. The individual may assist in the registration of products by preparing and submitting documentation needed for registration worldwide.
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Core job responsibilities for this function may include: Strategic Planning: · Assist in SOP development and review.
Provide regulatory input to product lifecycle planning.
Assist in the development of regional regulatory strategy and update strategy based upon regulatory changes.
Understand and investigate regulatory history/background of class, disease/ therapeutic/diagnostic context in order to assess regulatory implications for approval.
Determine trade issues to anticipate regulatory obstacles.
Determine and communicate submission and approval requirements.
Participate in risk-benefit analysis for regulatory compliance Premarket:
Monitor applications under regulatory review.
Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies.
Assist in preparation and review of regulatory submission to authorities Postmarket:
Maintain annual licenses, registrations, listings and patent information.
Assist compliance with product postmarketing approval requirements.
Assist in the review of advertising and promotional items.
Assess external communications relative to regulations.
Review regulatory aspects of contracts.
Assist with label development and review for compliance before release.
Submit and review change controls to determine the level of change and consequent submission requirements.
Contribute to the development and functioning of the crisis/ issue management program.
Ensure product safety issues and product-associated events are reported to regulatory agencies.
Provide regulatory input for product recalls and recall communications Job specific responsibilities may include (choose applicable areas and expand as appropriate). ·.
Medical writing · Advertising and promotion · Labeling · Controlled substances (e.g.
DEA) · Restricted substances (e.g.
REACH) · Compendial / standards · Import / export · Country specific regulatory support.
Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, engineering, or medical fields is preferred. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note: Higher education may compensate for years of experience.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com