Abbott Manager, Regulatory Affairs 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.
We are seeking an experienced Regulatory Affairs Project Manager or Regulatory Affairs Manager to oversee our Mitral and Tricuspid Valve Clip products at our Structural Heart division. This position will be based out of our Santa Clara facility and will be responsible for highly strategic class III new product development and submissions with the FDA and EU. The regulatory affairs manager will manage a team of regulatory affairs specialists, senior specialists and project managers.
Minimum of 7+ years regulatory affairs experience, preferably with class III medical devices including new product development. PMA and/or design dossier submissions experience strongly preferred. People management or mentorship experience strongly preferred.
• Develop new regulatory policies; processes and SOPs and train key personnel on them
• Evaluate regulatory risks of division policies; processes; procedures
• Provide regulatory input to product lifecycle planning
• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management
• Assist in the development of multicountry regulatory strategy and update strategy based upon regulatory changes
• Assist in regulatory due diligence for potential and new acquisitions
• Oversees the strategy implementation and operations for directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports
• Interacts with regulatory agency to expedite approval of pending registration
• Serves as regulatory liaison throughout product lifecycle
• Participates in some of the following: product plan development and implementation, regulatory strategy, risk management
• Ensures timely approval of new medical devices and continued approval of marketed products.
• Serves as regulatory representative to marketing, research teams and regulatory agencies.
• Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
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